None listed
Conditions
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
Interventions
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
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.
Sponsors
Flightpath Biosciences Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed