drugset / Trial / NCT07356713
A Study to Find a Suitable Dose of Exl-111 for Further Research
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants. The trials consists of 2 parts, as follows: Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo. Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo, and an active comparator (omalizumab).
Timeline
- Start
- 2026-01-08
- Primary completion
- 2026-12-07
- Completion
- 2026-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exl-111 | Unknown | — | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | — | Subcutaneous |