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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06183671




Registration number
NCT06183671
Ethics application status
Date submitted
20/11/2023
Date registered
27/12/2023
Date last updated
26/02/2024

Titles & IDs
Public title
JX09 SAD/MAD in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
Secondary ID [1] 0 0
JX09002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JX09 or placebo SAD
Treatment: Drugs - JX09 or placebo MAD
Treatment: Drugs - JX09

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

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

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


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence of adverse events and serious adverse events in health subjects.
Timepoint [1] 0 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 outcome [2] 0 0
Clinically significant change from baseline in physical examinations in health subjects
Timepoint [2] 0 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 outcome [3] 0 0
Clinically significant change from baseline in vital signs in health subjects
Timepoint [3] 0 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 outcome [4] 0 0
Clinically significant change from baseline in electrocardiograms in health subjects
Timepoint [4] 0 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 outcome [5] 0 0
Clinically significant change from baseline in clinical laboratory tests in health subjects
Timepoint [5] 0 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
Secondary outcome [1] 0 0
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Timepoint [1] 0 0
From Day 1 to Day 11
Secondary outcome [2] 0 0
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Timepoint [2] 0 0
From Day 1 to Day 11
Secondary outcome [3] 0 0
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Timepoint [3] 0 0
From Day 1 to Day 11
Secondary outcome [4] 0 0
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Timepoint [4] 0 0
From Day 1 to Day 11
Secondary outcome [5] 0 0
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Timepoint [5] 0 0
From Day 1 to Day 11
Secondary outcome [6] 0 0
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [6] 0 0
On day 1 and day 11
Secondary outcome [7] 0 0
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [7] 0 0
On day 1 and day 11
Secondary outcome [8] 0 0
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [8] 0 0
On day 1 and day 11
Secondary outcome [9] 0 0
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [9] 0 0
On day 1 and day 11
Secondary outcome [10] 0 0
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [10] 0 0
From day 2 to day 11
Secondary outcome [11] 0 0
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Timepoint [11] 0 0
From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Secondary outcome [12] 0 0
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Timepoint [12] 0 0
From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Secondary outcome [13] 0 0
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Timepoint [13] 0 0
From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Secondary outcome [14] 0 0
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [14] 0 0
on day 1 and day 11
Secondary outcome [15] 0 0
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [15] 0 0
on day 1 and day 11
Secondary outcome [16] 0 0
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Timepoint [16] 0 0
on day 1 and day 11
Secondary outcome [17] 0 0
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [17] 0 0
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 outcome [18] 0 0
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [18] 0 0
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 outcome [19] 0 0
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [19] 0 0
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 outcome [20] 0 0
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [20] 0 0
On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Secondary outcome [21] 0 0
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [21] 0 0
On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Secondary outcome [22] 0 0
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [22] 0 0
On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Secondary outcome [23] 0 0
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Timepoint [23] 0 0
On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ji Xing Pharmaceuticals Australia Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06183671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis, MD
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cherry Dong
Address 0 0
Country 0 0
Phone 0 0
86-21-8031 1808
Fax 0 0
Email 0 0
Cherry.dong@jixingbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06183671