Study Results
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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UNKNOWN
PHASE1
106 participants
INTERVENTIONAL
2023-07-06
2025-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
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.
JMKX003142 will be administered orally
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.
JMKX003142 will be administered orally
oral once
JMKX003142 FE experimental group
Participants will receive 2 Sequence regimens, with a washout period between treatments.
JMKX003142 will be administered orally
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.
Placebo in Cohorts 1 to 7
oral once
Placebo in 3 Cohorts
Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days.
Placebo in 3 Cohorts
oral once
Interventions
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JMKX003142 will be administered orally
oral once
JMKX003142 will be administered orally
oral once
JMKX003142 will be administered orally
oral once
Placebo in Cohorts 1 to 7
oral once
Placebo in 3 Cohorts
oral once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
Yes
Sponsors
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Zhejiang Hangyu Pharmaceutical Co., Ltd.
INDUSTRY
Jemincare
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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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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