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A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
Sponsor: Surmount Services, Inc.
Summary
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation. The study endpoints chosen for this study are commonly used for evaluating the safety, tolerability, and PK of single doses of IPs. No interim analysis is planned.
Official title: An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-09-15
Completion Date
2026-12-30
Last Updated
2026-08-26
Healthy Volunteers
Yes
Conditions
Interventions
Adalimumab
Single intracolonic administration of adalimumab
Guselkumab
Single intracolonic administration of guselkumab
SDL-001
SDL-001 is a formulation administered intracolonically with monoclonal antibodies