Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT03314402
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Tolerance, Pharmacokinetics of Jaktinib in Healthy Volunteers
Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: