NCT03314402

The Tolerance, Pharmacokinetics of Jaktinib in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib.

Detailed description

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Jaktinib Dihydrochloride Monohydrate	Active Substance
DRUG	placebo	Placebo

Timeline

• Start date: 2017-09-28
• Primary completion: 2018-08-30
• Completion: 2018-09-27
• First posted: 2017-10-19
• Last updated: 2019-03-01

Locations

1 site across 1 country: China