A PHASE I STUDY OF BRY10 IN HEALTHY MALE ADULTS

JRCT ID: jRCT2051240123

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Volunteers
• Date of first enrollment: 24/09/2024
• Target sample size: 72
• Study type: Interventional
• Intervention(s): BRY10: SC injection

Outcome(s)

Primary Outcome

safety, phamacokinetics, other
- Frequency, severity and relationship of adverse events including serious adverse events (SAE) to BRY10
- Laboratory values, vital signs and ECGs
- Plasma concentrations and pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, etc.)

Secondary Outcome

phamacokinetics, other
- Immunogenicity
- Effct of Ethinic difference on pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

- Signed ICF.
- Able to comply with the study protocol, in the investigators judgment.
- Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or <25.0 kg/m^2(Asian Cohorts) or >=18.5 kg/m^2 or <30.0 kg/m^2 (non-Asian Cohorts), and body weight >=50 kg at screening.
- Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.

Exclude criteria

- Clinically significant abnormal ECG at screening.
- Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.

Related Information

• Primary Sponsor: Kai Megumi