drugset / Trial / NCT04555850
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
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 0.5, 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.
Timeline
- Start
- 2018-07-30
- Primary completion
- 2019-02-18
- Completion
- 2019-07-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |
Indications
No indication recorded.