Resistant Hypertension
Conditions
Keywords
Hypertension, Health Volunteer, Pharmacokinetic, Food effect
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.
Interventions
DRUGJX09 or placebo SAD
For Part 1 SAD: JX09/placebo in capsule will be administered as a single oral dose. The nominal dose escalation scheme for the cohorts is 1, 3, 10, 30, 100, and 300 mg.
DRUGJX09 or placebo MAD
For Part 2 MAD: JX09/placebo in capsule will be administered for 11 days (once daily) The nominal dose escalation scheme for the cohorts is 2, 5, 10 and 20 mg.
DRUGJX09
For Part 3 FE: JX09 in capsule will be administered as a two single oral doses separated by 15 days. The nominal dose is 10 mg.
Sponsors
Novotech (Australia) Pty Limited
Ji Xing Pharmaceuticals Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double
Intervention model description
Double-Blind, Placebo-Controlled, Multi-Part
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects | From Day 1 to Day 11 | Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) 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 sodium by measuring 24-hour urine level |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | On day 1 and day 11 | Peak plasma concentration (CMAX) 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 the Last Measurable Concentration (AUC0-t) by measuring blood plasma |
| Urine pharmacokinetic parameters after multiple ascending dose in health subjects | on day 1 and day 11 | Cumulative amount of drug excreted by measuring urine |
| 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 aldosterone by measuring blood plasma |
Countries
Australia
Contacts
Primary ContactCherry Dong
Backup ContactYinghua Wang
Outcome results
None listed