NCT06137469

Assessment of Gastric Emptying by SHR20004 in Healthy Subjects

A Single-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Multiple Subcutaneous Injections of SHR20004 in Healthy Subjects on Gastric Emptying

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Acetaminophen/SHR20004	SHR20004 was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.
DRUG	Acetaminophen/Placebo	Placebo was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-03-16
• Completion: 2024-03-16
• First posted: 2023-11-18
• Last updated: 2024-12-02

Locations

1 site across 1 country: China