drugset / Trial / NCT06681389

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

NCT06681389 ↗

Phase 1 Terminated 35 enrolled NIBEC Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject NP-201 Unknown 200 mg Subcutaneous
Subject NP-201 Unknown 300 mg Subcutaneous
Subject NP-201 Unknown 400 mg Subcutaneous

Indications