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

Sponsor
Surmount Services, Inc.
Study ID
NCT07788807
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Nov 20, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
  • Experimental: Guselkumab + SDL-001 Formulation
  • Experimental: Adalimumab
  • Experimental: Adalimumab + SDL-001 Formulation

Primary Outcome Measure

Plasma PK parameters Cmax [ Time Frame: From Day 1 to Day 14 (EOS visit) ]

Central Contacts

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