JX09 SAD/MAD in Healthy Participants

Last updated: February 22, 2024
Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes And Hypertension

Williams Syndrome

Vascular Diseases

Treatment

JX09

JX09 or placebo SAD

JX09 or placebo MAD

Clinical Study ID

NCT06183671
JX09002
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged 18 to 55 years (inclusive)
  • In good health as deemed by the Investigator through a medical evaluation, includingmedical history, physical examination, and laboratory tests
  • Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg atScreening

Exclusion

Exclusion Criteria:

  • Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic,gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal,psychiatric, or other condition that in the opinion of the Investigator or MedicalMonitor would make is unsafe for the participant to join the study or fulfill itsrequirements.
  • A clinical abnormality or abnormal laboratory parameter(s) in the opinion of theInvestigator or Medical Monitor is likely to introduce additional risk or will affectdata interpretation.
  • Postural tachycardia or hypotension.
  • Female of childbearing potential who is pregnant, lactating, or planning to becomepregnant.

Study Design

Total Participants: 92
Treatment Group(s): 3
Primary Treatment: JX09
Phase: 1
Study Start date:
January 18, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Nucleus Network Pty Ltd

    Melbourne, 3004
    Australia

    Active - Recruiting

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