Healthy Clinical Trial
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
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.
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.
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