NCT04555850

A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Beijing Northland Biotech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Recombinant Human Thymosin β4	Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.
OTHER	Placebo	3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .

Timeline

• Start date: 2018-07-30
• Primary completion: 2019-02-18
• Completion: 2019-07-26
• First posted: 2020-09-21
• Last updated: 2020-09-29

Locations

1 site across 1 country: China