Status:
COMPLETED
A Phase I Safety Study of NVG-291 in Healthy Adults
Lead Sponsor:
NervGen Pharma
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 tol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2023
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05308953
Start Date
May 6 2021
End Date
July 3 2023
Last Update
January 10 2024
Active Locations (1)
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1
Nucleus Networks
Melbourne, Victoria, Australia, 3004