Healthy SubjectsPhase 1NCT07788807
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 study testing Adalimumab, Guselkumab and SDL-001 in people with Healthy Subjects, run by Surmount Services, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Adalimumab, Guselkumab and SDL-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants
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
- Being tested
- Adalimumab, Guselkumab, SDL-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Single intracolonic administration of adalimumab
GuselkumabDrug
Single intracolonic administration of guselkumab
SDL-001Drug
SDL-001 is a formulation administered intracolonically with monoclonal antibodies
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab | Experimental | Not described Receives: Drug: Guselkumab |
| Guselkumab + SDL-001 Formulation | Experimental | Not described Receives: Drug: Guselkumab; Drug: SDL-001 |
| Adalimumab | Experimental | Not described Receives: Drug: Adalimumab |
| Adalimumab + SDL-001 Formulation | Experimental | Not described Receives: Drug: Adalimumab; Drug: SDL-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK parameters Cmax
Measured: From Day 1 to Day 14 (EOS visit)
Plasma PK parameters- Tmax
Measured: From Day 1 to Day 14 (EOS visit)
Plasma PK parameters- AUC0-last
Measured: From Day 1 to Day 14 (EOS visit)
Serum concentration of adalimumab
Measured: From Day 1 to Day 14 (EOS visit)
Serum concentration of guselkumab
Measured: From Day 1 to Day 14 (EOS visit)
Secondary outcomes (6)
Incidence of TEAEs
Measured: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs
Measured: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal vital signs
Measured: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings
Measured: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal ECG readings
Measured: Days 1, 3,7 and day 14 (EOS visit)
Number of participants with abnormal Laboratory findings
Measured: Days 1, 3,7 and day 14 (EOS visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surmount Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Moller, Principal investigator, University of the Sunshine Coast Clinical Trials, Maroochydore, QLD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788807
- Sponsor's protocol ID
- SDL-001-101
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07788807
- Acronym / sponsor ID
- SDL-001-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Surmount Services, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabSingle intracolonic administration of adalimumab | Drug | Adalimumab, Adalimumab + SDL-001 Formulation |
| GuselkumabSingle intracolonic administration of guselkumab | Drug | Guselkumab, Guselkumab + SDL-001 Formulation |
| SDL-001SDL-001 is a formulation administered intracolonically with monoclonal antibodies | Drug | Adalimumab + SDL-001 Formulation, Guselkumab + SDL-001 Formulation |
Primary outcome
Plasma PK parameters Cmax
Time frame: From Day 1 to Day 14 (EOS visit)
Plasma PK parameters- Tmax
Time frame: From Day 1 to Day 14 (EOS visit)
Plasma PK parameters- AUC0-last
Time frame: From Day 1 to Day 14 (EOS visit)
Serum concentration of adalimumab
Time frame: From Day 1 to Day 14 (EOS visit)
Serum concentration of guselkumab
Time frame: From Day 1 to Day 14 (EOS visit)
6 secondary outcomes
Incidence of TEAEs
Time frame: From Day 1 to Day 14 (EOS visit)
Incidence of SAEs
Time frame: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal vital signs
Time frame: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal Physical examination findings
Time frame: From Day 1 to Day 14 (EOS visit)
Number of participants with abnormal ECG readings
Time frame: Days 1, 3,7 and day 14 (EOS visit)
Number of participants with abnormal Laboratory findings
Time frame: Days 1, 3,7 and day 14 (EOS visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Moller principal investigator
University of the Sunshine Coast Clinical Trials, Maroochydore, QLD
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab, Guselkumab and SDL-001 in people with Healthy Subjects, run by Surmount Services, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Moller (+61 7 5409 8659, cmoller@usc.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma PK parameters Cmax (time frame: From Day 1 to Day 14 (EOS visit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.