Phase 1 Clinical Study of JMKX003142 Tablets

Jemincare

Status and phase: Enrolling; Phase 1

Conditions: Safety and Tolerability

Treatments: Drug: JMKX003142 will be administered orally; Drug: Placebo in 3 Cohorts; Drug: Placebo in Cohorts 1 to 7

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06079541

JY-JM-035-101

Details and patient eligibility

About

Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female subjects aged 18-45 years (including boundary values)
2. Able to sign a written informed consent form
3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion criteria

1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
2. Participants in any other clinical study within 3 months prior to the first administration of this study
3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
4. Pregnant or lactating women

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 5 patient groups

JMKX003142 SAD experimental group

Experimental group

Description:

Participants will be randomized into 7 cohorts to receive single oral dose of JMKX003142 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort.

Treatment:

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

JMKX003142 MAD experimental group

Experimental group

Description:

Participants will be randomized into 3 cohorts to receive orally once -daily of JMKX003142 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort.

Treatment:

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

JMKX003142 FE experimental group

Experimental group

Description:

Participants will receive 2 Sequence regimens, with a washout period between treatments.

Treatment:

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

Drug: JMKX003142 will be administered orally

Placebo in Cohorts 1 to 7

Experimental group

Description:

Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1.

Treatment:

Drug: Placebo in Cohorts 1 to 7

Placebo in 3 Cohorts

Experimental group

Description:

Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days.

Treatment:

Drug: Placebo in 3 Cohorts