Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-14 @ 9:44 AM
Study NCT ID:
NCT02934412
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2016-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-1314 in Healthy Subjects
Sponsor:
Atridia Pty Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Subjects who are withdrawn for reasons other than safety may be replaced at the discretion of the sponsor.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: