NCT06175949

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-7085 Tablets Following Single and Multiple Oral Administrations, With Evaluation of Food Effects in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets in healthy subjects, with assessment of food effects

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	HRS-7085 Tablets	HRS-7085 Tablets, PO, 2mg、5mg、8mg、10mg、12mg、15mg, QD,
DRUG	HRS-7085 simulant	PO, 2mg、5mg、8mg、10mg、12mg、15mg, QD

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2023-12-19
• Last updated: 2023-12-19