This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers
NCT06926218 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-04-13
Summary
This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388
Conditions
- Healthy
Interventions
- DRUG
-
HSK47388
cohort 1 to cohort 5
- DRUG
-
cohort 1 to cohort 5
Sponsors & Collaborators
-
Haisco Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2025-07-31
- Completion
- 2025-09-30
Countries
- Australia
Study Locations
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