DMB-3113 Phase I

Phase 1

• Conditions: Healthy volunteers

• Registration Number: JPRN-jRCT2080223335
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

1)Healthy Japanese male adults;
2)The Body Mass Index (BMI) of the subjects must be from 17.6 to 26.4 kg/m2 at the time of the screening test; and
3)Subjects must take a screening test within the 4 weeks before the date of administration of the study drug; subjects must take a screening test before the date of administration of the study drug and exhibit no clinically abnormal findings in the judgment of the investigator or any of the subinvestigators.

Exclusion Criteria

1)Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
2)Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
3)Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
4)Concurrent or history of congestive cardiac failure;
5)Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study; or
6)Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified