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Phase I Study of Sintilimab in Healthy Chinese Male Subjects

NCT05337267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2023-08-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

sintilimab (after the change)

0.3mg/kg，I.V.，single dose

DRUG

sintilimab (before the change)

0.3mg/kg，I.V.，single dose

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2023-05-24
Completion
2023-07-24

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 NCT05337267 on ClinicalTrials.gov