Phase 1 Clinical Study of JMKX003142 Tablets

NCT06079541 | Unknown Phase 1

• 1 other identifier: JY-JM-035-101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (2)

• Number of the Adverse Events that are related to the single dose treatment

  single dose safety

  from baseline to Day 18

• Number of the Adverse Events that are related to the multiple dose treatment from

  multiple dose safety

  from baseline to Day 24

Study Arms (5)

JMKX003142 SAD experimental group

EXPERIMENTAL

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.

Drug: JMKX003142 will be administered orally

JMKX003142 MAD experimental group

EXPERIMENTAL

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.

Drug: JMKX003142 will be administered orally

JMKX003142 FE experimental group

EXPERIMENTAL

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

Drug: JMKX003142 will be administered orally

Placebo in Cohorts 1 to 7

EXPERIMENTAL

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

Drug: Placebo in Cohorts 1 to 7

Placebo in 3 Cohorts

EXPERIMENTAL

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

Drug: Placebo in 3 Cohorts

Interventions

JMKX003142 will be administered orally DRUG

oral once

Also known as: JMKX003142

JMKX003142 SAD experimental group

Placebo in Cohorts 1 to 7 DRUG

oral once

Also known as: Matching placebo will be administered orally

Placebo in Cohorts 1 to 7

Placebo in 3 Cohorts DRUG

oral once

Also known as: Matching placebo will be administered orally

Placebo in 3 Cohorts

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged 18-45 years (including boundary values)
• Able to sign a written informed consent form
• 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
• 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

You may not qualify if:

• 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
• Participants in any other clinical study within 3 months prior to the first administration of this study
• The investigators believe that the subject has other factors that are not suitable for participating in this experiment
• Pregnant or lactating women

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Xuening li

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianping Su

CONTACT

+86 15162481262; sujianping@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: July 6, 2023
• Primary Completion: July 31, 2024
• Study Completion: March 30, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-07

Locations

CN (1)