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NCT Number: NCT07788807

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

Single intracolonic administration of adalimumab

Guselkumab

Drug

Single intracolonic administration of guselkumab

SDL-001

Drug

SDL-001 is a formulation administered intracolonically with monoclonal antibodies

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)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Surmount Services, Inc.

Industry

Registry information

Official study title

An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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