NCT05347758

A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HRS-7535	Drug: HRS-7535
DRUG	Placebo	Drug: Placebo

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-09-18
• Completion: 2023-03-15
• First posted: 2022-04-26
• Last updated: 2022-04-26