NCT04232332

The Phase I Study of Recombinant Human Nerve Growth Factor Injection

The Phase I Study of Recombinant Human Nerve Growth Factor Injection in Healthy Chinese Volunteers on Safety, Tolerability and Pharmacokinetics: Randomized, Double-blind, Placebo-controlled, Single / Multiple Dose

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, single/multiple dose study of recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, tolerability and pharmacokinetics

Detailed description

This is a randomized, double-blind, placebo-controlled, single / multiple dose trial. recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, and pharmacokinetics.The volunteers will be given the drug by intramuscular injection. The main purpose of this trial is to investigate the safety, tolerability , pharmacokinetics and immunogenicity of Chinese healthy volunteers after intramuscular injection of recombinant human nerve growth factor injection, to provide a safe dose range for subsequent clinical trials, as well as a safe and reasonable drug delivery program.

Conditions

• Injury of Optic Nerve

Interventions

Type	Name	Description
DRUG	Recombinant human nerve growth factor injection,experimental	Intramuscular injection once on the first day according to dose requirements
DRUG	Recombinant human nerve growth factor injection,single dose	Intramuscular injection once on the first day according to dose requirements
DRUG	Recombinant human nerve growth factor injection,multiple dose	Intramuscular injection once daily for 7 days according to dose requirements

Timeline

• Start date: 2019-12-26
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2020-01-18
• Last updated: 2021-08-17

Locations

1 site across 1 country: China