Status:
RECRUITING
JX09 SAD/MAD in Healthy Participants
Lead Sponsor:
Ji Xing Pharmaceuticals Australia Pty Ltd
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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, pharmacodynam...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06183671
Start Date
January 18 2024
End Date
December 31 2024
Last Update
February 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nucleus Network Pty Ltd
Melbourne, Australia, 3004