NCT05983289

Single Escalating Dose Study Of HSK7653 In Healthy Subjects

A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	HSK7653	HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg
DRUG	Placebo	Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg

Timeline

• Start date: 2018-05-08
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

1 site across 1 country: China