Clinical trial NCT05308953: A Phase I Safety Study of NVG-291 in Healthy Adults
Official title: A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Lead sponsor: NervGen Pharma
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.


Eligibility criteria: Inclusion Criteria:

1. Healthy 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. 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. Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
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. For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
2. 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.
3. Blood pressure \> 160/95 at screening or on Day -1.
4. Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
5. History of allergic reaction to mannitol.
6. Presence of a tattoo, piercing, scar, or other dermatologic abnormality at the injection site (abdomen), that might interfere with the ability to assess injection site reactions
7. a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.
8. INR \> 1.4 or PTT \> 50 or platelets \<50x10\^3/µL at screening or on Day -1.
9. History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.
10. Test positive for use of drugs or alcohol at screening.
11. Positive hepatitis B, hepatitis C, or HIV test at screening.
12. Blood or plasma donation within 1 week prior to Day -1.
13. Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
14. Prior participation in this trial.
15. Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
16. 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.
17. Receipt of a COVID-19 vaccination within 3 weeks prior to Day -1
18. Subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale at screening

Primary outcomes:
measure: Adverse Events
timeFrame: Assessed through 7 days following the last dose of study drug
Secondary outcomes:
measure: Pharmacokinetic analysis (plasma)
timeFrame: Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only)
measure: Immunogenicity analysis
timeFrame: Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Networks
state: Victoria
Study officials:
affiliation: CMO
name: Daniel Miko, MD
role: STUDY_DIRECTOR
References: