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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210654

Enrollment

186

Registered

2022-03-09

Start date

2022-03-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prurigo nodularis with pruritus which are inadequately controlled by existing therapies

Interventions

subcutaneous administration of nemolizumab with vial or DCS formulations

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters	—

Contacts

Public Contactinformation Clinical

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.j+81-75-325-3279

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026