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JX09 SAD/MAD in Healthy Participants
Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd
Summary
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2024-01-18
Completion Date
2024-12-31
Last Updated
2026-10-29
Healthy Volunteers
Yes
Conditions
Interventions
JX09 or placebo SAD
For Part 1 SAD: JX09/placebo in capsule will be administered as a single oral dose. The nominal dose escalation scheme for the cohorts is 1, 3, 10, 30, 100, and 300 mg.
JX09 or placebo MAD
For Part 2 MAD: JX09/placebo in capsule will be administered for 11 days (once daily) The nominal dose escalation scheme for the cohorts is 2, 5, 10 and 20 mg.
JX09
For Part 3 FE: JX09 in capsule will be administered as a two single oral doses separated by 15 days. The nominal dose is 10 mg.
Locations (1)
Nucleus Network Pty Ltd
Melbourne, Australia