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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04868760
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Ipilimumab — DRUG
    Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
  • IBI310 — DRUG
    Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.

Study Details

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

Key Dates

Start date
May 31, 2021
Status verified
Oct 2022
Primary completion
May 2, 2022
Completion
May 2, 2022

Study Design

Enrollment
148 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group B: ipilimumab
    Ipilimumab, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes.
  • Experimental: Group A: IBI310
    IBI 310, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes.

Primary Outcome Measure

Area Under the Concentration-time Curve (AUC0-inf) [ Time Frame: From pre-dose to 1848hrs (78day) ]

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