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Safety, Tolerability and PK of SHR1314 in axSpA

NCT03704428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-01-13

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

SHR-1314

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fei Sun, MD · People's Liberation Army General Hospital

  • Xin Chang, MD · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2020-01-14
Completion
2020-01-14

Countries

  • China

Study Locations

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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 NCT03704428 on ClinicalTrials.gov