A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects

ConditionBiosimilarity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorGan & Lee Pharmaceuticals.

About this trial

This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects.

It is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.

Eligibility criteria

Qualifiers

1.Voluntarily sign the informed consent form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.

Disqualifiers

1.History of drug abuse within 1 year prior to screening, or positive predose drug abuse screening result at Visit 2 (V2); or history of alcohol abuse within 6 months prior to screening, or positive predose alcohol breath test result at V2.

Trial design

Treatments tested in this trial

  • GLR1044 injection
  • Dupilumab Injection

Treatment groups

198 Participants
are divided into 2 treatment groups

Sponsors and collaborators