Phase 1 Clinical Study of JMKX003142 Tablets
NCT06079541 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2023-10-17
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
Interventions
- DRUG
-
JMKX003142 will be administered orally
oral once
- DRUG
-
JMKX003142 will be administered orally
oral once
- DRUG
-
JMKX003142 will be administered orally
oral once
- DRUG
-
Placebo in Cohorts 1 to 7
oral once
- DRUG
-
Placebo in 3 Cohorts
oral once
Sponsors & Collaborators
-
Zhejiang Hangyu Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Jemincare
lead INDUSTRY
Principal Investigators
-
Xuening li · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-06
- Primary Completion
- 2024-07-31
- Completion
- 2025-03-30
Countries
- China
Study Locations
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