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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascending Single Doses | Experimental | 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 |
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| Ascending Multiple Doses | Experimental | 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 |
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| Food Effect | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX09 or placebo SAD | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and serious adverse events in health subjects. | The number of AEs and SAEs by using Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | 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 |
| Clinically significant change from baseline in physical examinations in health subjects | 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. | 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 |
| Clinically significant change from baseline in vital signs in health subjects | The number of events that clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate. | 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 |
| Clinically significant change from baseline in electrocardiograms in health subjects | The number of events that clinically significant change from baseline in electrocardiograms by measuring heart rate, PR, QRS, QT and QTc interval. | 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 |
| Clinically significant change from baseline in clinical laboratory tests in health subjects | The number of events that clinically significant change from baseline in clinical laboratory tests by measuring clinical chemistry panel, complete blood count and coagulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects | Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma | From Day 1 to Day 11 |
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cherry Dong | Contact | 86-21-8031 1808 | Cherry.dong@jixingbio.com | |
| Yinghua Wang | Contact | 86-21-8031 1808 | Yinghua.wang@jixingbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Sam Francis, MD | Nucleus Network Pty Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Recruiting | Melbourne | 3004 | Australia |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Double-Blind, Placebo-Controlled, Multi-Part
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Double
| JX09 or placebo MAD | Drug | 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. |
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| JX09 | Drug | 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. |
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| 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 |
Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma |
| From Day 1 to Day 11 |
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects | Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma | From Day 1 to Day 11 |
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects | Peak plasma concentration (CMAX) by measuring blood plasma | From Day 1 to Day 11 |
| Plasma pharmacokinetic parameters after a single ascending dose in health subjects | Time of maximum concentration (TMAX) by measuring blood plasma | From Day 1 to Day 11 |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | Peak plasma concentration (CMAX) by measuring blood plasma | On day 1 and day 11 |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | Time of maximum concentration (TMAX) by measuring blood plasma | On day 1 and day 11 |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma | On day 1 and day 11 |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma | On day 1 and day 11 |
| Plasma pharmacokinetic parameters after multiple ascending dose in health subjects | Concentration at end of dosing interval by measuring blood plasma | From day 2 to day 11 |
| Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions | Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma | From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26 |
| Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions | Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma | From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26 |
| Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions | Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma | From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26 |
| Urine pharmacokinetic parameters after multiple ascending dose in health subjects | Cumulative amount of drug excreted by measuring urine | on day 1 and day 11 |
| Urine pharmacokinetic parameters after multiple ascending dose in health subjects | Fraction of the dose excreted renally by measuring urine | on day 1 and day 11 |
| Urine pharmacokinetic parameters after multiple ascending dose in health subjects | Renal clearance by measuring urine | on day 1 and day 11 |
| Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of aldosterone by measuring blood plasma | 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 |
| Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of cortisol by measuring blood plasma | 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 |
| Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of corticosterone by measuring blood plasma | 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 |
| Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of sodium by measuring 24-hour urine level | On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort |
| Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of potassium by measuring 24-hour urine level | On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort |
| Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of aldosterone by measuring 24-hour urine level | On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort |
| Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects | Change from baseline of cortisol by measuring 24-hour urine level | On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort |