JX09 SAD/MAD in Healthy Participants

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd
• Collaborator: Novotech (Australia) Pty Limited

Criteria

Inclusion Criteria:

• Male or female aged 18 to 55 years (inclusive)

• In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests

• Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening

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 Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.

• A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.

• Postural tachycardia or hypotension.

• Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.