A Phase I Safety Study of NVG-291 in Healthy Adults

• Status: Recruiting
• Trial end date: 2022-05-18
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into two parts, starting with Part 1 (SAD) and then Part 2 (MAD). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Part 2 (MAD), participants receive 1 dose every day for 14 days.

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

Details

• Lead Sponsor: NervGen Pharma

Criteria

Inclusion Criteria:

1. Healthy female subjects between 18 and 65 years old.

2. BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.

3. All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.

4. Part 1 (SAD): All subjects must be willing to abstain from sexual intercourse or to use adequate contraception during the study and for an additional 120 days after the follow-up visit.

5. Part 2 (MAD): All subjects must be postmenopausal

6. Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.

7. Subjects must provide written informed consent.

Exclusion Criteria:

1. A history (within the past year) or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality.

2. Blood pressure > 160/95 at screening or on Day -1.

3. Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.

4. History of allergic reaction to mannitol.

5. Presence of a tattoo, piercing, scar, or other dermatologic abnormality at the injection site (abdomen), a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.

6. International normalized unit (INR) > 1.4 or partial thromboplastin time (PTT) > 50 or platelets <50x10^3/µL at screening or on Day -1

7. History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.

8. Test positive for use of drugs or alcohol at screening or Day -1

9. Positive hepatitis B, hepatitis C, or HIV test at screening.

10. Blood or plasma donation within 30 days prior to Day -1.

11. Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.

12. Prior participation in this trial.

13. Female subjects that are breastfeeding or who have a positive pregnancy test at screening or Day -1

14. History of any condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent..

15. Receipt of a COVID-19 vaccination within 3 weeks prior to Day-1.