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

An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants

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.

Inclusion Criteria:

• In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of the study drug, at the discretion of the PI or designee.
• Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 and ≤ 100 kg.

Exclusion Criteria:

• Pregnant, planning to become pregnant, or currently breastfeeding
• Current or recent clinically significant infection
• Any history of inflammatory bowel disease
• History of malignancy, except for non-melanoma skin cancer excised