JX09 SAD/MAD in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Resistant Hypertension
• Intervention / Treatment: Drug: JX09 or placebo SAD; Drug: JX09 or placebo MAD; Drug: JX09

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cherry Dong; Phone Number: 86-21-8031 1808; Email: Cherry.dong@jixingbio.com
• Study Contact Backup: Name: Yinghua Wang; Phone Number: 86-21-8031 1808; Email: Yinghua.wang@jixingbio.com

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • Recruiting
    • Nucleus Network Pty Ltd
    • Contact: Sam Francis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ascending Single Doses; 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	Drug: JX09 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.
Experimental: Ascending Multiple Doses; 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	Drug: JX09 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.
Experimental: Food Effect; 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	Drug: JX09; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ji Xing Pharmaceuticals Australia Pty Ltd
• Collaborators: Novotech (Australia) Pty Limited
• Investigators: Principal Investigator: Sam Francis, MD, Nucleus Network Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Health Volunteer; Food effect; Pharmacokinetic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: JX09002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No