Bioequivalence of DMB-3115, a Usutekinumab Biosimilar, and Usutekinumab

Phase 1

• Conditions: Psoriasis

• Registration Number: JPRN-jRCT2071210135
• Lead Sponsor: Morita Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Japanese healthy males aged at least 18 years and at most 55 years at the time of signing the informed consent
2. Body mass index (BMI) = Body weight (kg) / (Height [m])^2: >=18.5 and <25.0 (at screening)
3. Subjects who exhibited no clinically abnormal findings in the judgment of the investigator or the subinvestigators at screening within 4 weeks before the first dosing, at medical observation, tests, and evaluations on the day before and pre-dose of the first dosing

Exclusion Criteria

1. Prior administration of ustekinumab or ustekinumab biosimilar;
2. Use of any other monoclonal antibodies or fusion proteins within the 9 months before the date of administration of the IMP and lack of well documented evidence that subject had no adverse reaction from previous exposure to monoclonal antibodies or fusion proteins;
3. History of hypersensitivity to any of the ingredients of Stelara and DMB-3115 or other drugs;
4. Use of any prescription drug or any over-the-counter (OTC) drug within the 2 weeks (or less than 5 x the half-life of that medication, whichever is longer) before the date of administration of the IMP (excluding localized use not intended to have systemic action and hormonal contraceptives, hormone replacement therapy and occasional use of paracetamol of up to 2 g per day), which, in the judgment of the Investigator or Sub-Investigators, may affect participation in this clinical study;
5. Subject has received live vaccines during the 8 weeks prior to Screening or has the intention of receiving a live vaccine at any time during the study;

Study & Design

• Study Type: Interventional
• Study Design: Not specified