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A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects

NCT04235933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-22

No results posted yet for this study

Summary

to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection in healthy adult Chinese subjects

Conditions

  • Healthy

Interventions

BIOLOGICAL

Tai Ai(RC18) 80mg

The patient received one treatment of RC18 80mg in the test group

BIOLOGICAL

Tai Ai(RC18) 160mg

The patient received one treatment of RC18 160mg in the test group

BIOLOGICAL

RC18 240mg

The patient received one treatment of RC18 240mg in the test group

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhijun Li, M.D. · The First Affiliated Hospital of Bengbu Medical University

  • Huan Zhou, M.D. · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2019-12-20
Completion
2019-12-20

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 NCT04235933 on ClinicalTrials.gov