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Trial record 1 of 1 for:    NVG-291
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A Phase I Safety Study of NVG-291 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT05308953
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
NervGen Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: NVG-291 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: NVG-291 SAD
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.
 Drug: NVG-291
NVG-291 is a drug injected under the skin (subcutaneous).

Other: Placebo
Salt water is being used as a placebo and will be injected under the skin (subcutaneous).
Experimental: NVG-291 MAD
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.
 Drug: NVG-291
NVG-291 is a drug injected under the skin (subcutaneous).

Other: Placebo
Salt water is being used as a placebo and will be injected under the skin (subcutaneous).
Experimental: NVG-291 MAD - Males and Premenopausal Females
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.
 Drug: NVG-291
NVG-291 is a drug injected under the skin (subcutaneous).

Other: Placebo
Salt water is being used as a placebo and will be injected under the skin (subcutaneous).


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Assessed through 7 days following the last dose of study drug ]
    number and frequency of adverse events


Secondary Outcome Measures :
  1. Pharmacokinetic analysis (plasma) [ Time Frame: Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only) ]
    measure of concentration of drug in blood plasma

  2. Immunogenicity analysis [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308953


Contacts
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Contact: Cara Casseday (604) 488-5421 info@nervgen.com
Contact: Steven Mulcahy (604) 488-5421 info@nervgen.com

Locations
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Australia, Victoria
Nucleus Networks Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Andrew Walker    +61 404 225 972    a.walker@nucleusnetwork.com.au   
Principal Investigator: Philip Ryan         
Sponsors and Collaborators
NervGen Pharma
Investigators
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Study Director: Daniel Miko, MD CMO
More Information
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Responsible Party: NervGen Pharma
ClinicalTrials.gov Identifier: NCT05308953    
Other Study ID Numbers: NVG-291-101
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries