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Not yet recruitingNCT07788807Updated Aug 26, 2026

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

A Phase 1 interventional study of Adalimumab and Guselkumab in Healthy Subjects, sponsored by Surmount Services, Inc.. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Surmount Services, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy Subjects
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Guselkumab

    Drug: Guselkumab

  • Experimental
    Guselkumab + SDL-001 Formulation

    Drug: Guselkumab · Drug: SDL-001

  • Experimental
    Adalimumab

    Drug: Adalimumab

  • Experimental
    Adalimumab + SDL-001 Formulation

    Drug: Adalimumab · Drug: SDL-001

Interventions

  • DrugAdalimumab

    Single intracolonic administration of adalimumab

  • DrugGuselkumab

    Single intracolonic administration of guselkumab

  • DrugSDL-001

    SDL-001 is a formulation administered intracolonically with monoclonal antibodies

05

What researchers measure

Primary outcomes

  1. Plasma PK parameters Cmax

    Time frame: From Day 1 to Day 14 (EOS visit)

  2. Plasma PK parameters- Tmax

    Time frame: From Day 1 to Day 14 (EOS visit)

  3. Plasma PK parameters- AUC0-last

    Time frame: From Day 1 to Day 14 (EOS visit)

  4. Serum concentration of adalimumab

    Time frame: From Day 1 to Day 14 (EOS visit)

  5. Serum concentration of guselkumab

    Time frame: From Day 1 to Day 14 (EOS visit)

Secondary outcomes

  1. Incidence of TEAEs

    Time frame: From Day 1 to Day 14 (EOS visit)

  2. Incidence of SAEs

    Time frame: From Day 1 to Day 14 (EOS visit)

  3. Number of participants with abnormal vital signs

    Time frame: From Day 1 to Day 14 (EOS visit)

  4. Number of participants with abnormal Physical examination findings

    Time frame: From Day 1 to Day 14 (EOS visit)

  5. Number of participants with abnormal ECG readings

    Time frame: Days 1, 3,7 and day 14 (EOS visit)

  6. Number of participants with abnormal Laboratory findings

    Time frame: Days 1, 3,7 and day 14 (EOS visit)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07788807
Lead sponsor
Surmount Services, Inc.
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Nov 20, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 26, 2026

Study contacts

Christopher Moller
Contact
cmoller@usc.edu.au
+61 7 5409 8659
Christopher Moller
principal investigator · University of the Sunshine Coast Clinical Trials, Maroochydore, QLD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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