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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05225857




Registration number
NCT05225857
Ethics application status
Date submitted
11/01/2022
Date registered
7/02/2022

Titles & IDs
Public title
A First-in-Human Study Evaluating AGA2118 in Men and Postmenopausal Women
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Absolute Bioavailability, Pharmacokinetics, and Pharmacodynamics of AGA2118 in Men and Postmenopausal Women
Secondary ID [1] 0 0
21-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AGA2118
Treatment: Drugs - Placebo

Experimental: AGA2118 - In SAD part, various single doses of AGA2118 will be administered to the participants via either SC injection or IV infusion. The starting dose was 0.3 mg/kg, with sequential escalation up to 15 mg/kg.

In MAD part, various multiple doses of AGA2118 will be administered every four weeks (Q4W) to the participants via SC injection for 12 weeks. The starting dose was 1 mg/kg, with sequential escalation up to 12 mg/kg.

Placebo comparator: Placebo - In SAD part, a single dose of placebo comparator will be used for each cohort of either SC or IV administration.

In MAD part, multiple doses of placebo comparator will be used for each cohort of SC administration.


Treatment: Drugs: AGA2118
Part 1 - SAD study: SAD participants in various cohorts will receive various single dose of AGA2118 via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive various multiple doses of AGA2118 Q4W via SC.

Treatment: Drugs: Placebo
Part 1 - SAD study: SAD participants in various cohorts will receive a single dose of placebo via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive multiple doses of placebo via SC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAE) in Part 1 (SAD).
Assessment method [1] 0 0
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Timepoint [1] 0 0
Up to 85 days
Primary outcome [2] 0 0
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 1 (SAD).
Assessment method [2] 0 0
Serum calcium tested at Day 2, 4, 6, 15, 29, 85.
Timepoint [2] 0 0
Up to 85 days
Primary outcome [3] 0 0
Number of participants with clinically significant changes in blood pressure in Part 1 (SAD).
Assessment method [3] 0 0
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85).
Timepoint [3] 0 0
Up to 85 days
Primary outcome [4] 0 0
Number of participants with clinically significant changes in heart rate in Part 1 (SAD).
Assessment method [4] 0 0
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 85.
Timepoint [4] 0 0
Up to 85 days
Primary outcome [5] 0 0
Number of participants with clinically significant changes in QTcF in Part 1 (SAD).
Assessment method [5] 0 0
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 43, 57, 71, 85.
Timepoint [5] 0 0
Up to 85 days
Primary outcome [6] 0 0
Number of participants with treatment-emergent adverse events (TEAE) in Part 2 (MAD).
Assessment method [6] 0 0
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Timepoint [6] 0 0
Up to 169 days
Primary outcome [7] 0 0
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 2 (MAD).
Assessment method [7] 0 0
Serum calcium tested at Day 2, 8, 15, 29, 36, 57, 64, 85, 169.
Timepoint [7] 0 0
Up to 169 days
Primary outcome [8] 0 0
Number of participants with clinically significant changes in blood pressure in Part 2 (MAD).
Assessment method [8] 0 0
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 4, 6, 8, 15, 22, 29, 36, 43, 57, 58, 60, 62, 64, 71, 78, 85, 99, 113, 127, 141, 155, 169).
Timepoint [8] 0 0
Up to 169 days
Primary outcome [9] 0 0
Number of participants with clinically significant changes in heart rate in Part 2 (MAD).
Assessment method [9] 0 0
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.
Timepoint [9] 0 0
Up to day 169
Primary outcome [10] 0 0
Number of participants with clinically significant changes in QTcF in Part 2 (MAD).
Assessment method [10] 0 0
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.
Timepoint [10] 0 0
Up to day 169
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) of AGA2118
Assessment method [1] 0 0
Maximum concentration of AGA2118 after dosing.
Timepoint [1] 0 0
Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Secondary outcome [2] 0 0
Time to maximum concentration (Tmax) of AGA2118
Assessment method [2] 0 0
Time to maximum concentration of AGA2118 after dosing.
Timepoint [2] 0 0
Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Secondary outcome [3] 0 0
Area under the concentration time curve (AUC)
Assessment method [3] 0 0
Definite integral of the curve describing the variation of AGA2118 in blood as a function of time.
Timepoint [3] 0 0
Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Assessment method [4] 0 0
Time it takes for maximum concentration to half of maximum concentration of AGA2118.
Timepoint [4] 0 0
Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169

Eligibility
Key inclusion criteria
1. Healthy men = 30 and = 65 years of age or postmenopausal women = 45 and = 65 years of age for SAD and MAD;
2. BMI = 18.5 and = 32 kg/m^2 (for SAD and MAD).
3. Generally healthy (as assessed by the investigator).
4. Nonsmokers, or light smokers, defined as = 3 cigarettes/day (or equivalent) (for SAD and MAD).
5. Able and willing to correctly and independently complete all study procedures and able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures (for SAD and MAD).
6. A male who is sterile or agrees to the following during the Treatment Period and for at least 6 months after the final dose of investigational product

* Refrain from donating fresh unwashed semen

Plus, either

* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent

OR

* Must agree to use contraception as detailed below

* Agree to use a male condom plus a female partner to use a highly effective method of contraception with a woman of childbearing potential who is not currently pregnant
* Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A bone fracture within 6 months (for SAD only).
2. Previous exposure to AGA2118 (for MAD only).
3. Any condition that would affect bone metabolism or has a history of low energy fractures as documented in medical history (for MAD only).
4. Administration of the any medications that known to affect bone metabolism within 6 months of Day 1 unless otherwise specified (for SAD and MAD).
5. Human immunodeficiency virus (HIV) infection (for SAD and MAD).
6. Active chronic hepatitis B (HBV) or hepatitis C (HCV) infection including hepatitis B surface antigen and hepatitis C antigen positive participants with or without abnormal liver enzymes (for SAD and MAD).
7. Evidence of any of the following (for SAD and MAD):

1. creatinine = 1.5 × ULN, or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at screening
2. current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range
3. known intolerance to calcium supplements
4. malignancy within the last 5 years, etc.

Study design
Purpose of the study
Treatment
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/01/2024
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Brisbane
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Angitia Biopharmaceuticals
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Angitia Australia Pty Ltd
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Angitia Medical Director
Address 0 0
Angitia Incorporated Limited
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05225857