Phase 1: testing Adalimumab for Healthy Subjects
This is a proof-of-concept study to see if 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.
Official registry: https://clinicaltrials.gov/study/NCT07788807 · Surmount Services, Inc. · enrollment listed as 18
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Adalimumab, Guselkumab, or SDL-001. The registry lists allocation as randomized. This is a proof-of-concept study to see if antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
They plan to enroll about 18 people at Maroochydore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants
Interventions: Adalimumab, Guselkumab, SDL-001
Primary outcome (registry wording): Plasma PK parameters Cmax
Who it is for (from inclusion criteria)
- Ages 18 Years to 45 Years
- 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 (body-mass index (BMI)) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 and ≤ 100 kg
Who the registry excludes
- 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
Public study contact (from the registry)
Christopher Moller
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- University of the Sunshine Coast Clinical Trials, Maroochydore — Maroochydore, Queensland, Australia (recruiting)
FAQ about this NCT record
Is NCT07788807 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07788807?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07788807?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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