NCT04326881

A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

A Single-Center, Randomized, Parallel, Open-Label Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.

Detailed description

This study will be a single-center, randomized, parallel, open-label, single dosing (SHR-1314 240mg) bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314. The study will consist of a 14-days screening period (-14\~-1 days); an observation period (1-3 days) and the follow-up period (4-113 days); Subjects will be randomly assigned to three group.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	SHR-1314	single dosing

Timeline

• Start date: 2020-04-07
• Primary completion: 2020-07-07
• Completion: 2020-11-30
• First posted: 2020-03-30
• Last updated: 2020-03-30

Regulatory

• FDA-regulated drug study