Single Dose Study of MK-6194 in Healthy Japanese Participants

JRCT ID: jRCT2051210183

Registered date:02/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 09/03/2022
• Target sample size: 48
• Study type: Interventional

Intervention(s)

- Drug: MK-6194
MK-6194 1-7.5 mg subcutaneously administered in sterile solution form once
- Drug: Placebo
5% glucose subcutaneously administered in sterile solution form once

Outcome(s)

• Primary Outcome: Adverse events

Secondary Outcome

- AUC0-last, AUC0-inf, Cmax, Tmax, apparent t1/2, CL/F and Vz/F
- Immunophenotyping of regulatory T cells

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male
• Include criteria: Healthy Japanese male between the ages of 20 and 55 years with BMI within 18 to 25 kg/m2 inclusive and weight >=50 kg
• Exclude criteria: History of clinically significant abnormalities or diseases

Related Information

• Primary Sponsor: Tanaka Yoshiyuki