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 | Not Yet Recruiting Phase 1

• 1 other identifier: SDL-001-101
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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 (6)

• 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)

Study Arms (4)

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

Interventions

Adalimumab DRUG

Single intracolonic administration of adalimumab

Adalimumab; Adalimumab + SDL-001 Formulation

Guselkumab DRUG

Single intracolonic administration of guselkumab

Guselkumab; Guselkumab + SDL-001 Formulation

SDL-001 DRUG

SDL-001 is a formulation administered intracolonically with monoclonal antibodies

Adalimumab + SDL-001 Formulation; Guselkumab + SDL-001 Formulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Surmount Services, Inc.: lead

MeSH Terms

Interventions

Adalimumab; guselkumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christopher Moller

  University of the Sunshine Coast Clinical Trials, Maroochydore, QLD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Moller

CONTACT

+61 7 5409 8659; cmoller@usc.edu.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08