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

NCT05308953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-01-10

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • NervGen Pharma

    lead INDUSTRY

Principal Investigators

  • Daniel Miko, MD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2023-06-04
Completion
2023-07-03

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308953 on ClinicalTrials.gov