A First-in-Human Study of AV-001 in Healthy Subjects

• Status: Completed
• Trial end date: 2021-03-10
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) and pharmacodynamics (PD) analysis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vasomune Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) approved informed consent prior to performing any of the Screening Visit procedures

2. Males and female subjects of nonchildbearing potential between 18 to 65 years of age, inclusive, at the Screening Visit

3. Male subjects must agree to use a highly effective form of contraception (e.g., abstinence, double-barrier methods, have had a vasectomy or have sexual partner(s) of nonchildbearing potential) at the time of the Screening Visit and for 30 days after the dose or last dose of IMP. Male subjects must also agree to not donate sperm for the duration of the study and until 90 days after the dose or last dose of IMP

4. Female subjects must be nonpregnant and nonlactating and either surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal for > 12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 U/mL at the Screening Visit for amenorrheic female subjects

5. Non smokers (or other nicotine use) as determined by history (no nicotine use over the past three months) and by negative urine cotinine concentration at the Screening Visit and admission

6. Body weight > 50 kg and <150 kg at the Screening Visit

7. Body mass index (BMI) between 19 and 32 kg/m2, inclusive, at the Screening Visit

8. Vital sign measurements at the Screening Visit and on Day 1 within the following ranges (measurements may be repeated once per the discretion of the Principal Investigator):

1. Systolic blood pressure: 110 to 139 mmHg

2. Diastolic blood pressure: 70 to 89 mmHg

3. Pulse rate: 40 to 90 bpm

4. Oral body temperature: 35.0°C to 37.5°C A subject should not be included if their standing vital signs (relative to sitting) show findings which, in the opinion of the Principal Investigator, are associated with the clinical manifestation of postural hypotension (i.e., absence of any other cause). These changes include either a > 20 mmHg decrease in systolic, a >10 mmHg decrease in DBP, a > 30 bpm increase in heart rate from sitting to standing or > 120 bpm

9. Healthy, determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations)

Exclusion Criteria:

1. Subject has clinically significant history or evidence of cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Principal Investigator or designee

2. Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs, in the opinion of the Principal Investigator

3. Subject has a history of autonomic dysfunction (e.g., a history of fainting, orthostatic hypotension)

4. Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study

5. Subject has history of alcohol and/or illicit drug abuse within 2 years of entry

6. Subject has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) type 1 and 2 antibodies

7. Subject has positive breath alcohol test for ethanol at the Screening Visit or admission.

8. Subject has positive urine drug test at the Screening Visit or admission

9. Female subjects are breastfeeding or female subjects with a positive serum pregnancy test at the Screening Visit or admission

10. Subject is unwilling to avoid consumption of xanthine containing products (e.g., caffeine in coffee, tea, chocolate) within 48 hours prior to admission until discharge from the clinical site

11. Subject is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site

12. Subject has donated blood (> 500 mL) or blood products within 2 months (56 days) prior to admission

13. Subject has used over-the-counter (OTC) medications (including vitamins), 7 days prior to admission or prescription medications or herbal remedies from 14 days prior to admission until the End-of-Study Visit. By exception, paracetamol/acetaminophen ≤ 1000 mg per day and hormonal replacement therapy are permitted

14. Subject has participated in a clinical study or used an investigational drug within 30 days or 5 × half lives (whichever is the longer interval) prior to the Screening Visit

15. Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the End of Study Visit

16. Subject has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures or containing PEG (i.e., GripaNait® cough syrup, Betadine® antiseptic solution/cream)

17. Subject is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study

18. Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study

19. Subject has a positive test result for SARS-CoV-2 before randomization

20. Subject has previously been enrolled in this clinical study

21. Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent)