JX09 SAD/MAD in Healthy Participants
- Conditions
- Resistant Hypertension
- Interventions
- Registration Number
- NCT06183671
- Lead Sponsor
- Ji Xing Pharmaceuticals Australia Pty Ltd
- 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, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ascending Multiple Doses JX09 or placebo MAD 32 participants, 4 multiple ascending dose (MAD) cohorts (Cohorts 7 to 10). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo Ascending Single Doses JX09 or placebo SAD 48 participants, 6 single ascending dose (SAD) cohorts (Cohorts 1 to 6). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo Food Effect JX09 12 participants,1 single-dose food effect (FE) cohort (Cohort 11), open-label, two-sequence, two-period, crossover design, participants will be randomly assigned to 1 of the 2 crossover sequences
- Primary Outcome Measures
Name Time Method The incidence of adverse events and serious adverse events in health subjects. For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26 The number of AEs and SAEs by using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Clinically significant change from baseline in physical examinations in health subjects For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26 The number of events that clinically significant change from baseline in physical examinations by measuring general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest, abdomen, skin, neurological extremities, etc.
Clinically significant change from baseline in vital signs in health subjects For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26 The number of events that clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate.
Clinically significant change from baseline in electrocardiograms in health subjects For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26 The number of events that clinically significant change from baseline in electrocardiograms by measuring heart rate, PR, QRS, QT and QTc interval.
Clinically significant change from baseline in clinical laboratory tests in health subjects For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26 The number of events that clinically significant change from baseline in clinical laboratory tests by measuring clinical chemistry panel, complete blood count and coagulation.
- Secondary Outcome Measures
Name Time Method Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort Change from baseline of corticosterone by measuring blood plasma
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort Change from baseline of cortisol by measuring 24-hour urine level
Plasma pharmacokinetic parameters after a single ascending dose in health subjects From Day 1 to Day 11 Time of maximum concentration (TMAX) by measuring blood plasma
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects From day 2 to day 11 Concentration at end of dosing interval by measuring blood plasma
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26 Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma
Urine pharmacokinetic parameters after multiple ascending dose in health subjects on day 1 and day 11 Renal clearance by measuring urine
Trial Locations
- Locations (1)
Nucleus Network Pty Ltd
🇦🇺Melbourne, Australia