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drugset / Trial / NCT04555824

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

NCT04555824 ↗

Phase 1 Completed 54 enrolled Beijing Northland Biotech. Co., Ltd.
RandomizedParallel-groupQuadruple-blindBasic science

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 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.

Timeline

Start
2017-07-17
Primary completion
2018-02-20
Completion
2018-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 0.05 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 0.25 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 0.5 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 2 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 5 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 12.5 ug/kg Intravenous
Subject Recombinant Human Thymosin β4 Protein / enzyme biologic 25 ug/kg Intravenous

Indications

No indication recorded.