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

ConditionHealthy Subjects

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorSurmount Services, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Adalimumab
Drug
Single intracolonic administration of adalimumab
Guselkumab
Drug
Single intracolonic administration of guselkumab
SDL-001
Drug
SDL-001 is a formulation administered intracolonically with monoclonal antibodies

Treatment groups

18 Participants

are divided into 4 treatment groups

Group A: GuselkumabExperimental treatment 1 intervention

Group B: Guselkumab + SDL-001 FormulationExperimental treatment 2 interventions

Group C: AdalimumabExperimental treatment 1 intervention

Group D: Adalimumab + SDL-001 FormulationExperimental treatment 2 interventions