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JX09 SAD/MAD in Healthy Participants

NCT06183671 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-02-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Ji Xing Pharmaceuticals Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Sam Francis, MD · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06183671 on ClinicalTrials.gov