NCT06182384

A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.

Conditions

• Moderate-to-Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	SHR-1314	Receive a single dose of 240mg SHR-1314 at every period (First period：1mL AI, injection two needles. Second period: 2mL AI, injection one needle).
DRUG	SHR-1314	Receive a single dose of 240mg SHR-1314 at every period (First period：2mL AI, injection one needle. Second period: 1mL AI, injection two needles).

Timeline

• Start date: 2023-12-24
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2023-12-26
• Last updated: 2024-06-14

Locations

1 site across 1 country: China