A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dosed of HSK36273 in Healthy Volunteers
NCT05742126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2023-02-23
Summary
This is a single-center, Phase 1, placebo and positive-controlled, randomized, partial-blind, integrated, sequential ascending dose / multiple ascending dose study.The safety, tolerability, pharmacokinetics and pharmacodynamics of multiple continuous IV infusion ascending doses of HSK36273 in healthy volunteers will be evaluated.
Conditions
- Healthy
Interventions
- DRUG
-
HSK36273
Multiple continuous IV infusion ascending doses for 5 days
- DRUG
-
Matching placebo
- DRUG
-
Heparin sodium injection
Matching positive control
Sponsors & Collaborators
-
Haisco Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-11
- Primary Completion
- 2022-09-12
- Completion
- 2022-09-15
Countries
- China
Study Locations
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