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Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

NCT04337437 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-07

No results posted yet for this study

Summary

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

Genakumab

150 mg/1ml/bottle, single subcutaneous injection.

DRUG

Placebo for this trial

The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rui Chen · Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-09-30
Completion
2020-09-30

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 NCT04337437 on ClinicalTrials.gov