JX09 SAD/MAD in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Resistant Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blind, Placebo-Controlled, Multi-Part

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double

Study Groups

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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

Group Type EXPERIMENTAL

JX09 or placebo SAD

Intervention Type 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.

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

Group Type EXPERIMENTAL

JX09 or placebo MAD

Intervention Type 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.

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

Group Type EXPERIMENTAL

JX09

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes