drugset / Trial / NCT06681389
A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis
RandomizedSequentialDouble-blindTreatment
Summary
This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate injection after subcutaneous (SC) injection of multiple doses in healthy adults and in the ulcerative colitis (UC) patient population.
Timeline
- Start
- 2024-11-25
- Primary completion
- 2025-07-18
- Completion
- 2025-09-04
Outcome
Outcome not reported
Stopped (Business): “Study was terminated at the end of Part A for strategic reasons (not due to lack of efficacy or safety issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NP-201 | Unknown | 200 mg | Subcutaneous |
| Subject | NP-201 | Unknown | 300 mg | Subcutaneous |
| Subject | NP-201 | Unknown | 400 mg | Subcutaneous |