A Phase 1 interventional study of Adalimumab and Guselkumab in Healthy Subjects, sponsored by Surmount Services, Inc.. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Surmount Services, Inc. · Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with Surmount Services, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Guselkumab
Drug: Guselkumab · Drug: SDL-001
Drug: Adalimumab
Drug: Adalimumab · Drug: SDL-001
Single intracolonic administration of adalimumab
Single intracolonic administration of guselkumab
SDL-001 is a formulation administered intracolonically with monoclonal antibodies
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)
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)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Adalimumab · Guselkumab