Healthy Volunteers Clinical Trial
Official title:
A Randomized, Double-blind,Dose-escalation Phase 1 Study to Assess the Safety, Tolerance, and Pharmacokinetics of Jaktinib,an Oral JAK2 Inhibitor, in Healthy Volunteers
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib.
The study is a randomized, double-blind phase 1 trial including 3 independent parts: single
ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics
part. SAD and MAD are dose-escalated tolerant study designed 8 cohorts and 5 cohorts in SAD
and MAD respectively. The aims of the study as below:
1. Evaluating the safety and tolerance of Jaktinib in healthy volunteers.
2. Evaluating the fasting pharmacokinetic parameters of Jaktinib in healthy volunteers.
3. Evaluating the postprandial pharmacokinetic parameters of jaktinib in healthy
volunteers.
4. Analysis the metabolites of Jaktinib
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