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

NCT05308953 | Completed Phase 1

• 1 other identifier: NVG-291-101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  number and frequency of adverse events

  Assessed through 7 days following the last dose of study drug

Secondary Outcomes (2)

• Pharmacokinetic analysis (plasma)

  Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only)

• Immunogenicity analysis

  Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only)

Study Arms (3)

NVG-291 SAD

EXPERIMENTAL

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; Other: Placebo

NVG-291 MAD

EXPERIMENTAL

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; Other: Placebo

NVG-291 MAD - Males and Premenopausal Females

EXPERIMENTAL

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; Other: Placebo

Interventions

NVG-291 DRUG

NVG-291 is a drug injected under the skin (subcutaneous).

NVG-291 MAD; NVG-291 MAD - Males and Premenopausal Females; NVG-291 SAD

Placebo OTHER

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

NVG-291 MAD; NVG-291 MAD - Males and Premenopausal Females; NVG-291 SAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NervGen Pharma: lead

Study Sites (1)

Nucleus Networks

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Daniel Miko, MD

  CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: May 6, 2021
• Primary Completion: June 4, 2023
• Study Completion: July 3, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)