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COMPLETED
NCT06183671
PHASE1

JX09 SAD/MAD in Healthy Participants

Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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