NCT02934412

A Study of SHR-1314 in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety and Pharmacokinetics of SHR-1314 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.

Detailed description

This study will consist of a 27-day screening period (Days -28 to -2), clinic check-in (Day -1), a treatment day (Day 1), a 10-week treatment period and a study completion evaluation (Day 71) as shown in above figure. A review of blinded interim PK data will be conducted by the Safety Review Committee (SRC) to confirm the study sampling schedule captures the full PK profile of SHR-1314. This interim analysis will be conducted for Cohort 1 and may be conducted for subsequent cohorts if serum SHR-1314 concentrations in Cohort 1 or any of the subsequent cohorts are below the limit of quantification of the assay preventing evaluation of the PK profile. The expected duration of participation for each subject will be up to 99 days. Subjects who are withdrawn for reasons other than safety may be replaced at the discretion of the sponsor.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	SHR-1314	Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
DRUG	placebo	Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.

Timeline

• Start date: 2016-08-22
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2016-10-17
• Last updated: 2017-11-14

Locations

1 site across 1 country: Australia