RecruitingPhase 1NCT06681389

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


Sponsor

NIBEC Co., Ltd.

Enrollment

24 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and appropriate dose of a new drug (NP-201 acetate) in two groups: healthy adults and people with mild-to-moderate active ulcerative colitis (an inflammatory bowel disease that causes sores in the large intestine). **You may be eligible if...** - You are between 18 and 60 years old - You are in generally good health (for the healthy volunteer portion) - Your BMI is between 18 and 32, and you weigh at least 50 kg - You have mild-to-moderate active ulcerative colitis (for the patient portion) - You are willing to use effective contraception throughout the study and for 90 days after **You may NOT be eligible if...** - You have significant heart, liver, kidney, or other major medical conditions - You are pregnant, breastfeeding, or planning pregnancy - You have recently used other experimental drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNP-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

DRUGPlacebo

Matching placebo administered across Part A and Part B


Locations(1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, Australia

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NCT06681389


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