A Phase 1 Study of Apraglutide (Single Dose Study)

JRCT ID: jRCT2031220579

Registered date:22/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: short bowel syndrome and intestinal failure (SBS-IF)
• Date of first enrollment: 11/03/2023
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Apraglutide (TA799) 2.5mg, 5mg, 10mg subcutaneously single administration and blood collection

Outcome(s)

• Primary Outcome: Plasma concentration of compound(s)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Both

Include criteria

The subjects will be individuals who meet all of the following criteria.
[1] Healthy Japanese men and women
[2] Individuals >=18 to <45 years of age at the time of informed consent
[3] Individuals who fully understand the details of the study and who are capable of providing written informed consent

Exclude criteria

Individuals meeting any of the following criteria will be excluded from the study.
[1] Past history of disease in organsystems considered unsuitable for this study
[2] Past history of disease or surgery that could affect pharmacokinetic or pharmacodynamic evaluation
[3] Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Kozaki Tomohito