Phase 1 Clinical Study of JMKX003142 Tablets

Phase 1

Recruiting

• Conditions: Safety and Tolerability
• Interventions: Drug: JMKX003142 will be administered orally; Drug: Placebo in Cohorts 1 to 7; Drug: Placebo in 3 Cohorts

• Registration Number: NCT06079541
• Lead Sponsor: Jemincare

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-06
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-07-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JMKX003142 SAD experimental group	JMKX003142 will be administered orally	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.
JMKX003142 FE experimental group	JMKX003142 will be administered orally	Participants will receive 2 Sequence regimens, with a washout period between treatments.
Placebo in Cohorts 1 to 7	Placebo in Cohorts 1 to 7	Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1.
Placebo in 3 Cohorts	Placebo in 3 Cohorts	Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days.
JMKX003142 MAD experimental group	JMKX003142 will be administered orally	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.

Primary Outcome Measures

Name	Time	Method
Number of the Adverse Events that are related to the single dose treatment	from baseline to Day 18	single dose safety
Number of the Adverse Events that are related to the multiple dose treatment from	from baseline to Day 24	multiple dose safety

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China