Healthy Subjects
Conditions
Brief summary
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.
Interventions
DRUGAdalimumab
Single intracolonic administration of adalimumab
DRUGGuselkumab
Single intracolonic administration of guselkumab
DRUGSDL-001
SDL-001 is a formulation administered intracolonically with monoclonal antibodies
Sponsors
Surmount Services, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma PK parameters- Tmax | From Day 1 to Day 14 (EOS visit) |
| Plasma PK parameters- AUC0-last | From Day 1 to Day 14 (EOS visit) |
| Serum concentration of adalimumab | From Day 1 to Day 14 (EOS visit) |
| Serum concentration of guselkumab | From Day 1 to Day 14 (EOS visit) |
| Plasma PK parameters Cmax | From Day 1 to Day 14 (EOS visit) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with abnormal Physical examination findings | From Day 1 to Day 14 (EOS visit) |
| Incidence of TEAEs | From Day 1 to Day 14 (EOS visit) |
| Number of participants with abnormal ECG readings | Days 1, 3,7 and day 14 (EOS visit) |
| Number of participants with abnormal Laboratory findings | Days 1, 3,7 and day 14 (EOS visit) |
| Incidence of SAEs | From Day 1 to Day 14 (EOS visit) |
| Number of participants with abnormal vital signs | From Day 1 to Day 14 (EOS visit) |
Contacts
CONTACTChristopher Moller
PRINCIPAL_INVESTIGATORChristopher Moller
University of the Sunshine Coast Clinical Trials, Maroochydore, QLD
Outcome results
None listed