Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT04514796
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab — DRUG
    SB5 (adalimumab), 40 mg, single-dose

Study Details

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Key Dates

Start date
Aug 13, 2020
Status verified
May 2021
Primary completion
May 15, 2021
Completion
May 15, 2021

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 40 mg/0.4 mL of SB5
    100 mg/mL of SB5
  • Active Comparator: 40 mg/0.8 mL of SB5
    50 mg/mL of SB5

Primary Outcome Measure

AUCinf [ Time Frame: Day 1 to Day 57 ]

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