JX09 SAD/MAD in Healthy Participants

Ji Xing Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Resistant Hypertension

Treatments: Drug: JX09 or placebo MAD; Drug: JX09 or placebo SAD; Drug: JX09

Study type: Interventional

Funder types: Industry

Identifiers

NCT06183671

JX09002

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 3 patient groups

Ascending Single Doses

Experimental group

Description:

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

Treatment:

Drug: JX09 or placebo SAD

Ascending Multiple Doses

Experimental group

Description:

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

Treatment:

Drug: JX09 or placebo MAD

Food Effect

Experimental group

Description:

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:

Drug: JX09