JX09 SAD/MAD in Healthy Participants

Resistant Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183671
• Other study ID #: JX09002
• Status: Recruiting
• Phase: Phase 1
• Start date: January 18, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: Cherry Dong
• Phone: 86-21-8031 1808
• Email: Cherry.dong[@]jixingbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals Australia Pty Ltd	Novotech (Australia) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Plasma pharmacokinetic parameters after multiple ascending dose in health subjects	Peak plasma concentration (CMAX) by measuring blood plasma	On day 1 and day 11
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Urine pharmacokinetic parameters after multiple ascending dose in health subjects	Cumulative amount of drug excreted by measuring urine	on day 1 and day 11
Secondary	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
Secondary	Urine pharmacokinetic parameters after multiple ascending dose in health subjects	Renal clearance by measuring urine	on day 1 and day 11
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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