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

NCT06681389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

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

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, MAD4- 400mg administered 4 weekly doses.

DRUG

Placebo

Matching placebo administered across Part A and Part B

Sponsors & Collaborators

  • NIBEC Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Michele DeSciscio, Dr. · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2025-07-18
Completion
2025-09-04

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681389 on ClinicalTrials.gov