Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-31 @ 2:19 AM
Study NCT ID:
NCT04555850
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
Sponsor:
Beijing Northland Biotech. Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-Controlled, Multiple Doses,Dose-escalation，Phase 1b Study of the Safety, Tolerability，Pharmacokinetics and the Potential Immunological Reaction of Recombinant Human Thymosin Beta4 in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
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:
The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
Detailed Description:
This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability pharmacokinetics and potential immune responses of multiple NL005 intravenous administration.
Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.
While observing the safety of the subjects in each dose group, about 5mL of venous blood was collected for the ADA study in healthy subjects 14 days and 28 days after the first administration of the drug.
Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.
While observing the safety of the subjects in each dose group, about 5mL of venous blood was collected for the ADA study in healthy subjects 14 days and 28 days after the first administration of the drug.
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?: