Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT04232332
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2020-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Phase I Study of Recombinant Human Nerve Growth Factor Injection
Sponsor:
Beijing Tongren Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: