NCT06681389

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

A Randomized, Double-Blind Phase1b/2a Clinical Study to Evaluate Efficacy, Safety and Tolerability of Subcutaneous Administration of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: NIBEC Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This Phase 1b/2a randomized, double-blinded study will be conducted in two parts - Phase 1b (Part A) in healthy volunteers and Phase 2a (Part B) in UC patients. This record relates only to Part A/Phase 1b study. This will be updated once Part A is complete. Part A (Multiple Ascending Doses-MAD): Up to a total of 24 healthy participants will be enrolled into three sequential cohorts (MAD1, MAD2, and MAD3) and randomized 6:2 to receive two dosing regimens of NP-201 acetate injection or placebo daily for 5 days

Conditions

• Healthy Adult Volunteers
• Active Ulcerative Colitis
• Active Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	NP-201 acetate injection (Part A)	Route of administration- Sub cutaneous. Dosage interval and frequency: MAD1-200mg daily for 5 days; MAD2- 300mg daily for 5 days, MAD3- 400mg daily for 5 days
DRUG	Placebo	Matching placebo administered across Part A and Part B

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-03-25
• Completion: 2025-05-05
• First posted: 2024-11-08
• Last updated: 2025-01-07

Locations

1 site across 1 country: Australia