Bioequivalence study of nemolizumab with vial and DCS formulations in healthy volunteers

JRCT ID: jRCT2031210654

Registered date:09/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prurigo nodularis with pruritus which are inadequately controlled by existing therapies
• Date of first enrollment: 23/03/2022
• Target sample size: 186
• Study type: Interventional
• Intervention(s): subcutaneous administration of nemolizumab with vial or DCS formulations

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 49age old
• Gender: Male

Include criteria

(1)Healthy men who are 20 to 49 years of age at the time of informed consent.
(2)BMI of 18.5 to 24.9 kg/m2

Exclude criteria

(1)Individuals with a history of hepatic, renal, cardiac and other cardiovascular, gastrointestinal, hematologic, or other diseases considered inappropriate for paticipation in the clinical study
(2)Individuals who are judged to be clinically abnormal by the principal (sub) investigator based on clinical tests, vital signs, and electrocardiogram.
(3)Individuals who are judged by the principal (sub) investigator to be unsuitable as subject.

Related Information

• Primary Sponsor: Tomoyuki Nishiura