Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects
NCT ID: NCT05907382
Last Updated: 2023-06-18
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
80 participants
INTERVENTIONAL
2023-05-09
2024-03-31
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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JMKX003002 SAD experimental group
Participants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 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.
JMKX003002 will be administered orally
oral once
JMKX003002 MAD experimental group
Participants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort.
JMKX003002 will be administered orally
oral once
JMKX003002 FE experimental group
Participants will receive 3 Sequence regimens, with a washout period between treatments.
JMKX003002 will be administered orally
oral once
Placebo in Cohorts 1 to 5
Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1.
Placebo in Cohorts 1 to 5
oral once
Placebo in 2 Cohorts
Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days.
Placebo in 2 Cohorts
oral once
Interventions
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JMKX003002 will be administered orally
oral once
JMKX003002 will be administered orally
oral once
JMKX003002 will be administered orally
oral once
Placebo in Cohorts 1 to 5
oral once
Placebo in 2 Cohorts
oral once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.
Exclusion Criteria
2. Subjects with history of or current malignancy;
3. Participant who the researchers believe that there are volunteers who are not suitable for
18 Years
45 Years
ALL
Yes
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Zhang
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jing Zhang
Role: primary
Other Identifiers
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JY-JM3002-101
Identifier Type: -
Identifier Source: org_study_id
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