Bioequivalence study of nemolizumab with vial and DCS formulations in healthy volunteers
Phase 1
- Conditions
- Prurigo nodularis with pruritus which are inadequately controlled by existing therapies
- Registration Number
- JPRN-jRCT2031210654
- Lead Sponsor
- Tomoyuki Nishiura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 186
Inclusion 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
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method