JX09 SAD/MAD in Healthy Participants

February 22, 2024 updated by: Ji Xing Pharmaceuticals Australia Pty Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events and serious adverse events in health subjects.
Time Frame: 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
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time Frame: 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
From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time Frame: From Day 1 to Day 11
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
Time Frame: From Day 1 to Day 11
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
Time Frame: From Day 1 to Day 11
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 Frame: From Day 1 to Day 11
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
Time Frame: On day 1 and day 11
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 Frame: On day 1 and day 11
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
Time Frame: On day 1 and day 11
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
Time Frame: On day 1 and day 11
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
Time Frame: From day 2 to day 11
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
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: on day 1 and day 11
Cumulative amount of drug excreted by measuring urine
on day 1 and day 11
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Time Frame: on day 1 and day 11
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
Time Frame: on day 1 and day 11
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
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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
Time Frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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
Time Frame: 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
On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ji Xing Pharmaceuticals Australia Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novotech (Australia) Pty Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sam Francis, MD, Nucleus Network Pty Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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