Colonic delivery of two antibodies to see if they reach the bloodstream in healthy people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study explores the tolerability and how the antibodies guselkumab and adalimumab behave when delivered via the colon. It uses single-dose administration to assess safety, tolerability, and pharmacokinetics, without planned interim analyses. The trial is designed for healthy subjects to see if colonic delivery can achieve systemic exposure. No results are available yet as the study is in early phases.

Why it matters

Who can join: the full rules

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:

* 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

Where it's running

• University of the Sunshine Coast Clinical Trials, Maroochydore
  Maroochydore, Queensland, Australia Recruiting

Study contacts

• Principal investigator: Christopher Moller — University of the Sunshine Coast Clinical Trials, Maroochydore, QLD
• Study coordinator: Christopher Moller
• Email: cmoller@usc.edu.au
• Phone: +61 7 5409 8659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.