RGB-19 Phase I Clinical Study

JRCT ID: jRCT2031230029

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Participants
• Date of first enrollment: 01/05/2023
• Target sample size: 110
• Study type: Interventional
• Intervention(s): RGB-19 injection or Tocilizumab injection

Outcome(s)

Primary Outcome

Maximum serum drug concentration (Cmax)
AUC from 0 hours (immediately before administration) to infinity (AUCinf)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

Male volunteers who voluntarily wish to participate in the study, have the capacity to provide consent, and have provided written informed consent to participate in the study.
Volunteers from 20 to 40 years of age (both inclusive) when signing informed consent.

• Exclude criteria: Volunteers previously exposed to tocilizumab, any other IL-6 inhibitors, or IL-6 receptor inhibitors.

Related Information

• Primary Sponsor: Watanabe Manabu