JX09 SAD/MAD in Healthy Participants

Phase 1UnknownNCT06183671

Ji Xing Pharmaceuticals Australia Pty Ltd92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

92

Conditions

Resistant Hypertension

Interventions

JX09 or placebo SADDRUG

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 MADDRUG

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.

JX09DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Australia

RECRUITING

Outcomes

Primary Outcomes

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

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

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.

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

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.

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

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.

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

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.

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

Central Contacts

Cherry Dong

CONTACT

86-21-8031 1808 Cherry.dong@jixingbio.com

Yinghua Wang

CONTACT

86-21-8031 1808 Yinghua.wang@jixingbio.com

Data from ClinicalTrials.gov

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NCT06183671 - JX09 SAD/MAD in Healthy Participants | Crick | Crick