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RECRUITING
NCT06681389
PHASE1

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

Sponsor: NIBEC Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-11-25

Completion Date

2025-05-05

Last Updated

2025-01-07

Healthy Volunteers

Yes

Interventions

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

Locations (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, Australia