NCT06183671

JX09 SAD/MAD in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-12-27
• Last updated: 2024-02-26

Locations

1 site across 1 country: Australia