Phase 1 Clinical Study of JMKX003142 Tablets

NCT ID: NCT06079541

Last Updated: 2023-10-17

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2025-03-30

Brief Summary

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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

Detailed Description

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Conditions

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Safety and Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JMKX003142 SAD experimental group

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.

Group Type EXPERIMENTAL

JMKX003142 will be administered orally

Intervention Type DRUG

oral once

JMKX003142 MAD experimental group

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.

Group Type EXPERIMENTAL

JMKX003142 will be administered orally

Intervention Type DRUG

oral once

JMKX003142 FE experimental group

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

Group Type EXPERIMENTAL

JMKX003142 will be administered orally

Intervention Type DRUG

oral once

Placebo in Cohorts 1 to 7

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

Group Type EXPERIMENTAL

Placebo in Cohorts 1 to 7

Intervention Type DRUG

oral once

Placebo in 3 Cohorts

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

Group Type EXPERIMENTAL

Placebo in 3 Cohorts

Intervention Type DRUG

oral once

Interventions

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JMKX003142 will be administered orally

oral once

Intervention Type DRUG

JMKX003142 will be administered orally

oral once

Intervention Type DRUG

JMKX003142 will be administered orally

oral once

Intervention Type DRUG

Placebo in Cohorts 1 to 7

oral once

Intervention Type DRUG

Placebo in 3 Cohorts

oral once

Intervention Type DRUG

Other Intervention Names

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JMKX003142 JMKX003142 JMKX003142 Matching placebo will be administered orally Matching placebo will be administered orally

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Hangyu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Jemincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xuening li

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jianping Su

Role: CONTACT

+86 15162481262

Facility Contacts

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Xuening Li

Role: primary

Other Identifiers

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JY-JM-035-101

Identifier Type: -

Identifier Source: org_study_id

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