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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05863442




Registration number
NCT05863442
Ethics application status
Date submitted
17/03/2023
Date registered
18/05/2023
Date last updated
24/11/2023

Titles & IDs
Public title
Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants
Scientific title
A First-in-human, Randomized, Double-blind, Parallel-group Study to Evaluate the PK, Safety, Tolerability, Immunogenicity, and PD Profile of a Single Intravenous Dose of TUR03 Compared With Soliris® in Healthy Adult Male Participants
Secondary ID [1] 0 0
TUR03-22-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Soliris 300 MG in 30 ML Injection
Treatment: Drugs - TUR03 300 MG in 30 ML Injection

Active comparator: Soliris -

Experimental: TUR03 -


Treatment: Drugs: Soliris 300 MG in 30 ML Injection
Active Comparator

Treatment: Drugs: TUR03 300 MG in 30 ML Injection
Investigational medicinal Product, eculizumab - Turgut
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants
Timepoint [1] 0 0
Day 1 - Day 57
Secondary outcome [1] 0 0
Eculizumab serum concentration-time profile
Timepoint [1] 0 0
Day 1 - Day 57
Secondary outcome [2] 0 0
Maximum serum concentration (Cmax)
Timepoint [2] 0 0
Day 1- Day 57
Secondary outcome [3] 0 0
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Timepoint [3] 0 0
Day 1- Day 57
Secondary outcome [4] 0 0
Time to Cmax
Timepoint [4] 0 0
Day 1 - Day 57
Secondary outcome [5] 0 0
Terminal half-life
Timepoint [5] 0 0
Day 1 - Day 57
Secondary outcome [6] 0 0
Volume of distribution during terminal phase after intravenous administration
Timepoint [6] 0 0
Day 1 - Day 57
Secondary outcome [7] 0 0
Terminal elimination rate constant
Timepoint [7] 0 0
Day 1 - Day 57
Secondary outcome [8] 0 0
Total serum clearance of drug after intravenous administration
Timepoint [8] 0 0
Day 1 - Day 57
Secondary outcome [9] 0 0
AEs and AESI
Timepoint [9] 0 0
Day 1 - Day 57
Secondary outcome [10] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Hematology
Timepoint [10] 0 0
Day 1 - Day 57
Secondary outcome [11] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - International normalized ratio
Timepoint [11] 0 0
Day 1 - Day 57
Secondary outcome [12] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Activated partial thromboplastin time
Timepoint [12] 0 0
Day 1 - Day 57
Secondary outcome [13] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Prothrombin time
Timepoint [13] 0 0
Day 1 - Day 57
Secondary outcome [14] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Urea
Timepoint [14] 0 0
Day 1 - Day 57
Secondary outcome [15] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Carbon dioxide (bicarbonate)
Timepoint [15] 0 0
Day 1 - Day 57
Secondary outcome [16] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatinine
Timepoint [16] 0 0
Day 1 - Day 57
Secondary outcome [17] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - AST
Timepoint [17] 0 0
Day 1 - Day 57
Secondary outcome [18] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALT
Timepoint [18] 0 0
Day 1 - Day 57
Secondary outcome [19] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALP
Timepoint [19] 0 0
Day 1 - Day 57
Secondary outcome [20] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Glucose (fasting)
Timepoint [20] 0 0
Day 1 - Day 57
Secondary outcome [21] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Gamma glutamyl transferase
Timepoint [21] 0 0
Day 1 - Day 57
Secondary outcome [22] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total Protein
Timepoint [22] 0 0
Day 1 - Day 57
Secondary outcome [23] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatine kinase
Timepoint [23] 0 0
Day 1 - Day 57
Secondary outcome [24] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Potassium
Timepoint [24] 0 0
Day 1 - Day 57
Secondary outcome [25] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Lactate dehydrogenase
Timepoint [25] 0 0
Day 1 - Day 57
Secondary outcome [26] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Sodium
Timepoint [26] 0 0
Day 1 - Day 57
Secondary outcome [27] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Albumin
Timepoint [27] 0 0
Day 1 - Day 57
Secondary outcome [28] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Chloride
Timepoint [28] 0 0
Day 1 - Day 57
Secondary outcome [29] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total and direct bilirubin
Timepoint [29] 0 0
Day 1 - Day 57
Secondary outcome [30] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Calcium
Timepoint [30] 0 0
Day 1 - Day 57
Secondary outcome [31] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Triglycerides
Timepoint [31] 0 0
Day 1 - Day 57
Secondary outcome [32] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Phosphate
Timepoint [32] 0 0
Day 1 - Day 57
Secondary outcome [33] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Cholesterol
Timepoint [33] 0 0
Day 1 - Day 57
Secondary outcome [34] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Leukocytes
Timepoint [34] 0 0
Day 1 - Day 57
Secondary outcome [35] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Red blood cells
Timepoint [35] 0 0
Day 1 - Day 57
Secondary outcome [36] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Protein
Timepoint [36] 0 0
Day 1 - Day 57
Secondary outcome [37] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - pH
Timepoint [37] 0 0
Day 1 - Day 57
Secondary outcome [38] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Bilirubin
Timepoint [38] 0 0
Day 1 - Day 57
Secondary outcome [39] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Nitrite
Timepoint [39] 0 0
Day 1 - Day 57
Secondary outcome [40] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Urobilinogen
Timepoint [40] 0 0
Day 1 - Day 57
Secondary outcome [41] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Specific gravity
Timepoint [41] 0 0
Day 1 - Day 57
Secondary outcome [42] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Ketones
Timepoint [42] 0 0
Day 1 - Day 57
Secondary outcome [43] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Glucose
Timepoint [43] 0 0
Day 1 - Day 57
Secondary outcome [44] 0 0
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Microscopy
Timepoint [44] 0 0
Day 1 - Day 57
Secondary outcome [45] 0 0
Changes in vital signs - Blood Pressure
Timepoint [45] 0 0
Day 1 - Day 57
Secondary outcome [46] 0 0
Changes in vital signs - Pulse rate
Timepoint [46] 0 0
Day 1 - Day 57
Secondary outcome [47] 0 0
Changes in vital signs - Body Temperature
Timepoint [47] 0 0
Day 1 - Day 57
Secondary outcome [48] 0 0
Changes in Electrocardiograms (ECG) - Heart rate
Timepoint [48] 0 0
Day 1 - Day 57
Secondary outcome [49] 0 0
Changes in Electrocardiograms (ECG) - PR interval
Timepoint [49] 0 0
Day 1 - Day 57
Secondary outcome [50] 0 0
Changes in Electrocardiograms (ECG) - RR interval
Timepoint [50] 0 0
Day 1 - Day 57
Secondary outcome [51] 0 0
Changes in Electrocardiograms (ECG) - QRS duration
Timepoint [51] 0 0
Day 1 - Day 57
Secondary outcome [52] 0 0
Changes in Electrocardiograms (ECG) - QT interval
Timepoint [52] 0 0
Day 1 - Day 57
Secondary outcome [53] 0 0
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 via physical examination
Timepoint [53] 0 0
Day 1 - Day 57
Secondary outcome [54] 0 0
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Frequency of antidrug antibodies (ADAs)
Timepoint [54] 0 0
Day 1 - Day 57
Secondary outcome [55] 0 0
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Antidrug antibody titers
Timepoint [55] 0 0
Day 1 - Day 57
Secondary outcome [56] 0 0
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Neutralizing antibodies (NAbs)
Timepoint [56] 0 0
Day 1 - Day 57
Secondary outcome [57] 0 0
PD profile of TUR03 and Soliris - ABEC (0-1344) CH50
Timepoint [57] 0 0
Day 1 - Day 57
Secondary outcome [58] 0 0
PD profile of TUR03 and Soliris - AUEC(0-1344) CH50
Timepoint [58] 0 0
Day 1 - Day 57
Secondary outcome [59] 0 0
PD profile of TUR03 and Soliris - Emin CH50
Timepoint [59] 0 0
Day 1 - Day 57
Secondary outcome [60] 0 0
PD profile of TUR03 and Soliris - Tmin CH50
Timepoint [60] 0 0
Day 1 - Day 57

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if ALL of the following criteria apply:

1. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
2. Participants assigned male at birth who are =18 years and =45 years old at the time of signing the ICF.
3. Body weight =50 kg and =90 kg and body mass index (BMI) =18.00 kg/m2 and =30.00 kg/m2 at Screening and Day -1.
4. Participants must be healthy as determined by the Investigator, based on medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations at Screening and Day -1, as follows:

1. Hematology and coagulation results within reference ranges.
2. Liver function panel analyte values =1.5 × upper limits of normal (ULN), which include aspartate transaminase, alanine transaminase, and total bilirubin (for participants with Gilbert's Syndrome, total bilirubin =3.0 × ULN is allowed if direct bilirubin is =50%), alkaline phosphatase, and gamma glutamyl transferase at Screening.
3. Urinalysis within reference ranges or showing no clinically significant findings.

NOTE: One repeat of clinical laboratory tests is allowed at the discretion of the Investigator.
5. Participants must have documented evidence of prior complete vaccination with meningococcal vaccines against N. meningitidis serogroup B at any time and against serogroups A, C, W, and Y within 5 years prior to Screening in line with local immunization requirements or must agree to be vaccinated against N. meningitidis during the study.
6. Nonsterilized participants with partners of childbearing potential must agree to take appropriate contraceptive measures (as described in Section 10.4) from Day 1 until 5 months after IP administration and refrain from donating sperm during this period. NOTE: Participants with pregnant partners are excluded.
7. Nonsmoker or occasional smoker, ie, smokes =10 cigarettes (or equivalent of tobacco- or nicotine-containing products) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site.
8. Ability and willingness to abstain from alcohol from 48 hours before admission to the study site on Day -1, during in-house observation at the study site until discharge, and for 24 hours prior to ambulatory visits.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if ANY of the following criteria apply:

1. Known or suspected hereditary or acquired complement deficiency.
2. History of meningococcal infection.
3. History or evidence of a clinically significant disorder (including psychiatric disorders), condition, or disease that, in the opinion of the Investigator and Medical Monitor or designee, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. EXCEPTION: Fully resolved childhood asthma is not exclusionary.
4. History of splenectomy.
5. History of surgery or major trauma within 12 weeks of Screening, or surgery planned during the study.
6. A recent history (within 1 week prior to IP administration) or presence or suspicion of current active systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory condition, in the opinion of the Investigator.
7. History of or current invasive malignancy (excluding basal or squamous cell carcinoma that has been fully resected with no evidence of metastatic disease for 1 year).
8. History of ongoing seborrheic dermatitis or eczema.
9. History of clinically significant headaches that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
10. History of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to IP administration.
11. History of a drug- or food-induced severe hypersensitivity reaction (eg, immunologic or nonimmunologic anaphylaxis).
12. Known hypersensitivity reaction to penicillin and/or cephalosporin that, in the opinion of the Investigator, would pose a risk to participant safety.
13. Known hypersensitivity to any component of TUR03 or Soliris, murine proteins, or other monoclonal antibodies.
14. Known hypersensitivity to any component of meningococcal vaccines, including those containing diphtheria toxoid, or a life-threatening reaction after previous administration of a vaccine containing similar components.
15. Hypertension at Screening or Day -1 (defined as a systolic blood pressure [BP] >140 mm Hg and/or a diastolic BP >90 mm Hg, confirmed by a single repeat measurement that same day) or a history of hypertension requiring pharmacological intervention.
16. Proteinuria at Screening or Day -1 (with a urine dipstick value of 1+ or above)..
17. Tests positive for human immunodeficiency virus (HIV 1 and 2), hepatitis B virus surface antigen, hepatitis B core antibody, or hepatitis C virus.
18. Tests positive for tuberculosis (TB) using the QuantiFERON®-TB Gold test at Screening or, if indeterminant result on the first test, tests positive or indeterminant on repeat QuantiFERON-TB Gold test.
19. Positive screen for alcohol by breath test and/or potential drugs of abuse by urine drug screen at Screening or Day -1. NOTE: One repeat screen is allowed at the discretion of the Investigator.
20. History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to Screening.
21. Prior exposure to eculizumab or similar compounds (ie, a monoclonal antibody that specifically binds to the complement protein C5).
22. Use of immunoglobulins or iron supplementation within 3 months prior to Screening.
23. Use of any over-the-counter (OTC) medications, herbal remedies such as St. John's Wort extract, or prescription medications within 7 days or 5 half lives (whichever is longer) prior to IP administration. EXCEPTIONS: Vitamins, dietary supplements, and paracetamol (up to 4 g per day, but <1 g in 4 hours) for analgesia are not exclusionary.
24. Use of other investigational drugs (or is currently using an investigational device) within 60 days or 5 half-lives (whichever is longer) prior to IP administration.
25. Vaccination with a live vaccine within 30 days prior to IP administration, or vaccination with an inactivated vaccine or approved COVID-19 vaccine within 14 days prior to IP administration, or planning to get vaccinated during the study period. EXCEPTIONS: Receipt of required meningococcal vaccinations per protocol is not exclusionary.
26. Veins unsuitable for venous blood collection.
27. Donated blood (including blood products) or experienced loss of blood =500 mL within 30 days of Screening, or donated plasma within 7 days of Screening.
28. Participant is a family member or employee of the Investigator or Sponsor.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/10/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Limited - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Turgut Ardika PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.
Trial website
https://clinicaltrials.gov/study/NCT05863442
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05863442