NCT05308953

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

A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: NervGen Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2021-05-06
• Primary completion: 2023-06-04
• Completion: 2023-07-03
• First posted: 2022-04-04
• Last updated: 2024-01-10

Locations

1 site across 1 country: Australia