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SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 3 SOR102 QD | Experimental | SOR102 once a day for 6 weeks SOR102 oral capsules |
|
| Part 3 SOR102 BID | Experimental | SOR102 twice a day for 6 weeks SOR102 oral capsules |
|
| Part 3 Placebo | Placebo Comparator | Placebo for twice a day for 6 weeks Placebo oral capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOR102 | Drug | SOR102 capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events following oral dosing | After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group | Up to 6 weeks in Part 3 or at the time of study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| SOR102 concentrations following oral dosing | To determine the concentration of SOR102 in serum, urine and feces. | Up to 6 weeks in Part 3 or at the time of study discontinuation |
| Incidence of positive ADAs to SOR102 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos C Sattler, MD | Sorriso Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia Exploratory Medicine | Tbilisi | Georgia | ||||
| Arensia Exploratory Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41242336 | Derived | Jairath V, Danese S, D'Haens GR, Feagan BG, Peyrin-Biroulet L, Sands BE, Gaemers I, Westfall M, Terry AQ, Roberts KJ, Barbat S, Wedel P, Benson JM, Sattler C. Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):34-45. doi: 10.1016/S2468-1253(25)00296-1. Epub 2025 Nov 13. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2025 | |
| Reset | Dec 15, 2025 | |
| Release | Jan 15, 2026 | |
| Reset | Jan 30, 2026 | |
| Release | Feb 4, 2026 | |
| Reset | Feb 23, 2026 | |
| Release | Apr 1, 2026 | |
| Reset | Apr 21, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2025 | Dec 15, 2025 | |||
| Jan 15, 2026 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Drug |
Matching placebo capsules |
|
To assess the incidence of positive ADAs to SOR102.
| Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation |
| Incidence of positive neutralizing ADA | To assess the incidence of positive neutralizing ADA to SOR102 and its monomers in patients with positive ADA to SOR102. | Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation |
| Kyiv |
| Ukraine |
| Jan 30, 2026 |
| Feb 4, 2026 | Feb 23, 2026 |
| Apr 1, 2026 | Apr 21, 2026 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |