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Trial registered on ANZCTR


Registration number
ACTRN12623001153606
Ethics application status
Approved
Date submitted
18/10/2023
Date registered
8/11/2023
Date last updated
2/09/2024
Date data sharing statement initially provided
8/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FP-100 in Healthy Adults
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of FP-100 in Healthy Adult Participants
Secondary ID [1] 310678 0
Protocol FP-100-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lyme disease 331591 0
Condition category
Condition code
Infection 328324 328324 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 72 healthy men or women will be enrolled in this study. There will be two parts to the study.

In the first part of the study approximately 48 healthy men and women will be enrolled in up to 6 single ascending dose cohorts comprising 8 subjects each. Participants within each cohort will be randomised to receive a single dose of either oral FP-100 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below.
Cohort 1a: 100mg
Cohort 1b: 400mg
Cohort 1c: 800mg
Cohort 1d: 1600mg
Cohort 1e: 2000mg
Cohort 1f: 2400 mg

One cohort may receive FP-100 twice - once while fasting and again 7 days later after food.

In the second part of the study approximately 24 healthy men and women will be enrolled into up to 3 multiple ascending dose cohorts comprising 8 subjects each. Participants within each cohort will be randomised to receive multiple doses of either oral FP-100 (6 subjects) or oral placebo (2 subjects). Each dose regimen will be administered every day for 7 days (7 total doses). All doses will be administered under direct observation in the Phase 1 unit. The dose selection and dosing regimen for the second part of the study will be based upon the data from the first part of the study.
Intervention code [1] 327086 0
Treatment: Drugs
Comparator / control treatment
Placebo control group. Placebo is a capsule filled with microcrystalline cellulose matched to the FP-100 capsule
Control group
Placebo

Outcomes
Primary outcome [1] 336174 0
To evaluate the safety of single doses of FP-100 when compared with placebo in healthy participants through the assessment of: treatment-emergent adverse events, physical examination data, vital sign data including blood pressure, heart rate, temperature and respiratory rate, ECG data, and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel)
Timepoint [1] 336174 0
Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final visit which is Day 22 post dose. Physical examinations in Cohorts 1a, 1b, 1c, 1d and 1e and 1f will be conducted at screening, Day -1, Day 4, and Day 8 post dose. Physical examinations in the cohort selected as the food effect cohort will be conducted at screening, Day -1, Day 4, and Day 15 post dose. Clinical laboratory assessments of blood and urine in Cohorts 1a, 1b, 1c, 1d, 1e and 1f will be collected at screening, Day -1, Day 1, Day 2 and Day 8 post dose. Clinical laboratory assessments of blood and urine in the food effect cohort will be collected at screening, Day -1, Day 1, Day 2, Day 8, Day 9, and Day 15 post dose. ECGs in Cohorts 1a, 1b, 1c, 1d 1e and 1f will be collected at screening, on Day 1 predose and at 2, 4 and 8 hours after dosing, on Day 2 at 24 hours post dose, and on Day 8 post dose. ECGs in the food effect cohort will be collected at screening, on Day 1 predose and at 2, 4 and 8 hours after dosing, on Day 2 at 24 hours post dose, on Day 8 predose and at 2, 4 and 8 hours after dosing, on Day 9 at 24 hours post dose, and on Day 15 post dose. Vital signs in Cohorts 1a, 1b, 1c, 1d, 1e and 1f will be collected at screening, on Day -1, on Day 1 predose and at 1, 2, 4, 8 and 12 hours after dosing, on Day 2 at 24 hours post dose, on Day 4 and on Day 8 post dose. Vital signs in the food effect cohort will be collected at screening, on Day -1, on Day 1 predose and at 1, 2, 4, 8 and 12 hours after dosing, on Day 2 at 24 hours post dose, on Day 4, on Day 8 predose and at 1, 2, 4, 8 and 12 hours after dosing, on Day 9 at 24 hours post dose, on Day 10, and on Day 15 post dose.
Primary outcome [2] 336175 0
To evaluate the safety of multiple doses of FP-100 when compared with placebo in healthy participants through the assessment of: treatment-emergent adverse events, physical examination data, vital sign data including blood pressure, heart rate, temperature and respiratory rate, ECG data, and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel)
Timepoint [2] 336175 0
Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final visit which is Day 21 post dose. Physical examinations will be conducted at screening, Day -1, Day 3, Day 5, Day 8 and Day 21 post dose. Clinical laboratory assessments of blood and urine will be collected at screening, Day -1, Day 1, Day 2, Day 5, Day 7 and Day 21 post dose. ECGs will be collected at screening, on Day 1 predose and at 2, 4 and 8 hours after dosing, on Day 3, on Day 5, on Day 7 predose and at 2, 4 and 8 hours after dosing, on Day 8, and on Day 21 post dose. Vital signs will be collected at screening, on Day -1, on Day 1 through Day 7 predose and at 1, 2, 4, 8 and 12 hours after dosing, on Day 8, and on Day 21 post dose.

Secondary outcome [1] 427210 0
Plasma concentrations of FP-100 after a single oral dose of FP-100
Timepoint [1] 427210 0
In Cohorts 1a, 1b, 1c, 1d, 1e, and 1f plasma samples will be collected on Day 1 pre-dose and then at 15, 30, 45, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours post dose. A 24 hour and 36 hour post dosing sample will be collected on Day 2, a 48 hour post dosing sample will be collected on Day 3 and a 72 hour post dosing sample will be collected on Day 4. Participants will return on Day 5 and Day 6 for a 96 hour and 120 hour sample to be collected. In the food effect cohort plasma samples will also be collected on Day 8 pre-dose and then at 15, 30, 45, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours post dose. A 24 hour and 36 hour post dosing sample will be collected on Day 9, a 48 hour post dosing sample will be collected on Day 10 and a 72 hour post dosing sample will be collected on Day 11. Participants will return on Day 12 and Day 13 for a 96 hour and 120 hour sample to be collected.
Secondary outcome [2] 427211 0
Plasma concentrations of FP-100 after multiple oral doses of FP-100
Timepoint [2] 427211 0
On Day 1 plasma samples will be collected pre-dose and then at 15, 30, 45, 60, and 90 minutes, and 2, 4, 6, 8, and 12 hours post dose. On Day 2, a 24 hour post Day 1 dose plasma sample will be collected pre-dose and 1 hour post dose. On Day 3 and Day 5, a plasma sample will be collected pre-dose and at 2 and 6 hours post dose. On Day 7, plasma samples will be collected pre-dose and at 15, 30, 45, 60 and 90 minutes, and 2, 4, 6, 8 and 12 hours post dose. A 24-hour post Day 7 dose sample will be collected on Day 8 .

Eligibility
Key inclusion criteria
1. Participants of any sex, gender, race or ethnicity, aged between 18 and 55 years of age at time of consent.
2. Participants must meet the following conditions:
a. Participants must be of non-childbearing potential, defined as
i. Postmenopausal (at least 1 year without menses and confirmed with follicle-stimulating hormone (FSH) levels greater than or equal to 40 mIU/mL at screening); or,
ii. Documented surgically sterile
or
b. If of childbearing potential, be non-pregnant (defined by a negative serum pregnancy test) and not lactating and agree to use highly effective contraception from screening through 30 days post dose.
c. Male participants, if engaging in sexual intercourse with a partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post dose and agree not to donate sperm during this period.
d. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
i. Established hormonal contraceptives (eg, oral contraceptive pills, long-acting implantable hormones, injectable hormones)
ii. Intrauterine device or intrauterine hormone-releasing system
iii. Bilateral tubal occlusion
iv. Vasectomised participant/partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner
e. Participants who do not engage in heterosexual intercourse will be considered abstinent and do not require contraception. Women of childbearing potential who choose complete abstinence must continue to have pregnancy tests as per protocol. The reliability of sexual abstinence needs to be evaluated by the Investigator in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Abstinence must be an ongoing and usual lifestyle of the participant and complete abstinence must be maintained from screening through 30 days post dose.
3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug.
4. Weigh at least 50kg (males) and 45kg (females) at the time of screening
5. Have a body mass index between 18 and 32 kg/m2 at the time of screening.
6. Negative SARS-CoV2 test if required and per site standards.
7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments.
8. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose until the end of study assessments have been completed, except for limited use of paracetamol or in the case of necessary treatment of adverse events. Limited use of paracetamol is defined as 2 consecutive days of up to 4000 mg/day. These limits do not apply to its use for the necessary medical treatment of adverse events.
9. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug.
10. Participants who smoke no more than 2 cigarettes, pipes, cigars or e-cigarettes or equivalent per week, including nicotine products, from 3 months prior to screening, can be included in the study but must be willing to abstain from smoking/using nicotine products during the confinement period.
11. Willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known allergy to FP-100.
2. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening.
3. History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, or tachycardia.
4. Has a clinically significant history or presence of electrocardiogram (ECG) findings.
5. Has clinically significant laboratory abnormalities
6. History of moderate or severe substance abuse defined by the DSM-V criteria within 5 years prior to screening.
7. History of moderate or severe psychiatric illness, based on physician’s judgement.
8. History of alcohol use disorder defined as an average daily intake of more than 3 units, or an average weekly intake of more than 21 units, where 1 unit is equivalent to 1 can or bottle (355mL) of beer, or 1 measure (25mL) of spirits, or 1 glass (175 mL) of wine within 5 years prior to screening.
9. Positive alcohol breath test or urine test for drugs of abuse at screening and at the time of admission.
10. Positive serology panel (including hepatitis B surface antigen and/or confirmed current hepatitis C infection) and/or positive human immunodeficiency virus antibody/p24 antigen screen.
11. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
12. Has prior exposure to FP-100.
13. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening.
14. Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the participant at risk as a result of participation in the study.
15. Is from a vulnerable population as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for GCP E6 (R2), including but not limited to, employees or family member of the research staff conducting the study, or of the Sponsor, or the HREC.
16. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements.
17. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the participant unsuitable for enrollment.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated simple randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
This is an exploratory study and therefore it is not powered for inferential statistical analyses. It is anticipated that approximately 72 healthy male or female adult participants will be enrolled. This sample size is commonly used in studies of this design to obtain sufficient information on the safety, tolerability and PK

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2024
Actual
6/05/2024
Date of last participant enrolment
Anticipated
14/10/2024
Actual
Date of last data collection
Anticipated
4/11/2024
Actual
Sample size
Target
72
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41410 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 314899 0
Commercial sector/Industry
Name [1] 314899 0
Flightpath Biosciences Australia Pty Ltd
Country [1] 314899 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Flightpath Biosciences Australia Pty Ltd
Address
Level 17, HWT Tower, 40 City Road, Southbank VIC 3006
Country
Australia
Secondary sponsor category [1] 316902 0
None
Name [1] 316902 0
Address [1] 316902 0
Country [1] 316902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313892 0
Bellberry Limited Human Research Ethics Committee
Ethics committee address [1] 313892 0
29 Glen Osmond Road EASTWOOD SOUTH AUSTRALIA 5063
Ethics committee country [1] 313892 0
Australia
Date submitted for ethics approval [1] 313892 0
01/11/2023
Approval date [1] 313892 0
01/12/2023
Ethics approval number [1] 313892 0

Summary
Brief summary
This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called FP-100. FP-100 is being developed for the treatment of patients with Lyme disease

You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old.

In Cohorts 1a through 1f, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Cohorts 2a through 2c, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo.

For subjects in Cohorts 1a, 1b, 1c, 1e and 1f, study participation will require 22 calendar days which will include 4 days (3 nights) in the CRU.
For subjects in Cohort 1d, study participation will require 22 calendar days which will include one stay of 7 days (6 nights) in the CRU.
For subjects in Cohorts 2a, 2b and 2c, study participation will require 22 calendar days which will include 9 days (8 nights) in the CRU.

It is hoped that this research will help determine the safety of FP-100 when given to healthy men or women so that it can be tested in patients with Lyme disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129698 0
Dr Christopher Argent
Address 129698 0
Scientia Clinical Research Ltd. Levels 5 and 6, Bright Building, Corner High and Avoca Sts., Randwick, NSW 2031
Country 129698 0
Australia
Phone 129698 0
+61 02 9382 5844
Fax 129698 0
Email 129698 0
[email protected]
Contact person for public queries
Name 129699 0
Puja Motwani
Address 129699 0
Scientia Clinical Research Ltd. Levels 5 and 6, Bright Building, Corner High and Avoca Sts., Randwick, NSW 2031
Country 129699 0
Australia
Phone 129699 0
+61 2 9382 5820
Fax 129699 0
Email 129699 0
[email protected]
Contact person for scientific queries
Name 129700 0
Puja Motwani
Address 129700 0
Scientia Clinical Research Ltd. Levels 5 and 6, Bright Building, Corner High and Avoca Sts., Randwick, NSW 2031
Country 129700 0
Australia
Phone 129700 0
+61 2 9382 5820
Fax 129700 0
Email 129700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate participant data will be available from this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.