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

NCT07788807 — Phase 1, Not yet recruiting, 18 participants, Surmount Services, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07788807
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	18 (Estimated)
Sponsor	Surmount Services, Inc. (Industry)
Conditions	Healthy Subjects
Interventions	Adalimumab, Guselkumab, SDL-001 (Drug)
Dates	start 2026-09-15 (estimated), primary completion 2026-11-20 (estimated), completion 2026-12-30 (estimated), first posted 2026-08-26, last updated 2026-08-26

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions
Guselkumab	Experimental	Drug: Guselkumab
Guselkumab + SDL-001 Formulation	Experimental	Drug: Guselkumab; Drug: SDL-001
Adalimumab	Experimental	Drug: Adalimumab
Adalimumab + SDL-001 Formulation	Experimental	Drug: Adalimumab; Drug: SDL-001

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

+Outcome measures

Primary outcomes

Plasma PK parameters Cmax [From Day 1 to Day 14 (EOS visit)]
Plasma PK parameters- Tmax [From Day 1 to Day 14 (EOS visit)]
Plasma PK parameters- AUC0-last [From Day 1 to Day 14 (EOS visit)]
Serum concentration of adalimumab [From Day 1 to Day 14 (EOS visit)]
Serum concentration of guselkumab [From Day 1 to Day 14 (EOS visit)]

Secondary outcomes

Incidence of TEAEs [From Day 1 to Day 14 (EOS visit)]
Incidence of SAEs [From Day 1 to Day 14 (EOS visit)]
Number of participants with abnormal vital signs [From Day 1 to Day 14 (EOS visit)]
Number of participants with abnormal Physical examination findings [From Day 1 to Day 14 (EOS visit)]
Number of participants with abnormal ECG readings [Days 1, 3,7 and day 14 (EOS visit)]
Number of participants with abnormal Laboratory findings [Days 1, 3,7 and day 14 (EOS visit)]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Investigators

Christopher Moller, Principal investigator, University of the Sunshine Coast Clinical Trials, Maroochydore, QLD