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A Study of SHR-1314 in Healthy Subjects

NCT02934412 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Atridia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Nicholas Farinola, B.Sc,BMBS · Royal Adelaide Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-22
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934412 on ClinicalTrials.gov