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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
NervGen Pharma·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Spinal Cord Injury
Drug/Device/Intervention
NVG-291
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
NervGen Pharma
Location
Melbourne, Australia
Timeline & enrollment
Phase
Phase 1
Start date
May 06, 2021
End date
Dec 01, 2022
Enrollment
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 cordOther injury of lumbar spinal cordInjury of spinal cord, level unspecifiedOther and unspecified injuries of thoracic spinal cordOther and unspecified injuries of cervical spinal cord
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05308953
Type
Non-Device Trial
About this record

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.