Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537050
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
A Randomized Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects The Purpose of the Study is to Evaluate the Safety Tolerability After Administration of Single Dose or Multiple Doses and the Pharmacokinetics PK of Single and Multiple Doses of JX2105 in Healthy Study Participants
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the safety tolerability after administration of single dose or multiple doses and the pharmacokinetics PK of single and multiple doses of JX2105 in healthy study participants
Detailed Description:
Overall design
This study is divided into 3 parts Part 1 single-dose escalation study SAD Part 2 multiple-dose escalation study MAD Part 3 food-effect study FE Part 1 includes 7 cohorts Part 2 includes 23cohorts and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokineticpharmacodynamics of JX2105 and its metabolites The doses of part 2 and 3 will be designed according to the PK parameters from Part 1 Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg
This study is divided into 3 parts Part 1 single-dose escalation study SAD Part 2 multiple-dose escalation study MAD Part 3 food-effect study FE Part 1 includes 7 cohorts Part 2 includes 23cohorts and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokineticpharmacodynamics of JX2105 and its metabolites The doses of part 2 and 3 will be designed according to the PK parameters from Part 1 Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None