A Phase I Safety Study of NVG-291 in Healthy Adults
- Registration Number
- NCT05308953
- Lead Sponsor
- NervGen Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Healthy subjects between 18 and 65 years old.
- BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.
- All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.
- 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.
- Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
- Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.
- Subjects must provide written informed consent.
Exclusion Criteria
- For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
- 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.
- Blood pressure > 160/95 at screening or on Day -1.
- Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
- History of allergic reaction to mannitol.
- 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
- a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.
- INR > 1.4 or PTT > 50 or platelets <50x10^3/µL at screening or on Day -1.
- History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.
- Test positive for use of drugs or alcohol at screening.
- Positive hepatitis B, hepatitis C, or HIV test at screening.
- Blood or plasma donation within 1 week prior to Day -1.
- Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
- Prior participation in this trial.
- Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
- 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.
- Receipt of a COVID-19 vaccination within 3 weeks prior to Day -1
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NVG-291 MAD Placebo Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. NVG-291 SAD Placebo Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. NVG-291 MAD - Males and Premenopausal Females Placebo Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2. NVG-291 SAD NVG-291 Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. NVG-291 MAD NVG-291 Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. NVG-291 MAD - Males and Premenopausal Females NVG-291 Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2.
- Primary Outcome Measures
Name Time Method Adverse Events Assessed through 7 days following the last dose of study drug number and frequency of adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetic analysis (plasma) Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only) measure of concentration of drug in blood plasma
Immunogenicity analysis Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only) number of participants with confirmed and titer results for the presence of anti-drug antibodies
Trial Locations
- Locations (1)
Nucleus Networks
🇦🇺Melbourne, Victoria, Australia