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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

NCT07788807 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Adalimumab

Single intracolonic administration of adalimumab

DRUG

Guselkumab

Single intracolonic administration of guselkumab

DRUG

SDL-001

SDL-001 is a formulation administered intracolonically with monoclonal antibodies

Sponsors & Collaborators

  • Surmount Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Moller · University of the Sunshine Coast Clinical Trials, Maroochydore, QLD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2026-11-20
Completion
2026-12-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788807 on ClinicalTrials.gov