NCT05742126

A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dosed of HSK36273 in Healthy Volunteers

A Randomized, Partial-Blind, Placebo and Positive-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HSK36273 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	HSK36273	Multiple continuous IV infusion ascending doses for 5 days
DRUG	Placebo	Matching placebo
DRUG	Heparin sodium injection	Matching positive control

Timeline

• Start date: 2022-04-11
• Primary completion: 2022-09-12
• Completion: 2022-09-15
• First posted: 2023-02-23
• Last updated: 2023-02-23

Locations

1 site across 1 country: China