NCT03710681

A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis

Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.

Detailed description

16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Conditions

• Moderate-to-severe Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	SHR-1314	Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Timeline

• Start date: 2018-08-02
• Primary completion: 2019-04-21
• Completion: 2019-07-30
• First posted: 2018-10-18
• Last updated: 2018-10-18

Locations

2 sites across 1 country: China