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A Phase I Safety Study of NVG-291 in Healthy Adults - Trial NCT05308953

Access comprehensive clinical trial information for NCT05308953 through Pure Global AI's free database. This Phase 1 trial is sponsored by NervGen Pharma and is currently Recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 72 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05308953
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05308953
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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

Study Focus

Spinal Cord Injury

NVG-291

Interventional

drug

Sponsor & Location

NervGen Pharma

Melbourne, Australia

Timeline & Enrollment

Phase 1

May 06, 2021

Dec 01, 2022

72 participants

Primary Outcome

Incidence of Adverse Events

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 two parts, starting with Part 1 (SAD)
 and then Part 2 (MAD). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Part
 2 (MAD), participants receive 1 dose every day for 14 days.

ICD-10 Classifications

Sequelae of injury of spinal cord
Other injury of lumbar spinal cord
Injury of spinal cord, level unspecified
Other and unspecified injuries of thoracic spinal cord
Other and unspecified injuries of cervical spinal cord

Data Source

ClinicalTrials.gov

NCT05308953

Non-Device Trial