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A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects

NCT04839744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-22

No results posted yet for this study

Summary

This study is designed to evaluate the comparability of TG103 injection subject to changes in the manufacturing process in Chinese healthy male subjects.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

TG103 produced by the modified manufacturing process

Drug: TG103 (a modified manufacturing process), 15mg, SC

DRUG

TG103 produced by the original manufacturing process

Drug: TG103 (the original manufacturing process), 15mg, SC

Sponsors & Collaborators

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Li · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2021-06-15
Completion
2021-07-02

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 NCT04839744 on ClinicalTrials.gov