Testing JX09 for resistant hypertension in healthy adults
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
This study is testing a new drug called JX09 in healthy adults to see if it’s safe and how it works for treating resistant high blood pressure.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Corxel Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Melbourne) |
| Trial ID | NCT06183671 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of JX09 in healthy adult participants. The study is designed as a randomized, double-blind, placebo-controlled trial, involving both single and multiple ascending doses of the drug. Participants will receive either JX09 or a placebo to assess the effects of the medication and how food intake may influence its pharmacokinetics.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 55 with a body mass index between 18 and 32 kg/m2.
Not a fit: Patients with significant health conditions or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for patients with resistant hypertension.
How similar studies have performed: While this approach is common in early-phase trials, the specific drug JX09 is novel and has not been tested in this manner before.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Melbourne
- Nucleus Network Pty Ltd — Melbourne, Australia (Recruiting)
Study contacts
- Principal investigator: Sam Francis, MD — Nucleus Network Pty Ltd.
- Study coordinator: Cherry Dong
- Email: Cherry.dong@jixingbio.com
- Phone: 86-21-8031 1808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.