MedTrace Logo

A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers

NCT04868760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-04-13

No results posted yet for this study

Summary

This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab （YERVOY）

Conditions

  • Healthy Subjects

Interventions

DRUG

Ipilimumab

Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

DRUG

IBI310

Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-05-02
Completion
2022-05-02

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04868760 on ClinicalTrials.gov