NCT06681389 is a Phase 1 clinical trial of NP-201 acetate injection (Part A) in Healthy Adult Volunteers, sponsored by NIBEC Co., Ltd..

Who is sponsoring NCT06681389?

NCT06681389 is sponsored by NIBEC Co., Ltd..

What drugs are being tested in NCT06681389?

Interventions in NCT06681389: NP-201 acetate injection (Part A), Placebo.

What condition does NCT06681389 study?

NCT06681389 studies Healthy Adult Volunteers, Active Ulcerative Colitis, Active Ulcerative Colitis (UC).

Is NCT06681389 still recruiting?

NCT06681389 is currently recruiting now. Last updated 7 January 2025.

Last reviewed 2025-01-07 · How we verify

NCT06681389

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 7 January 2025

What this trial tests

Phase 1 trial testing NP-201 acetate injection (Part A) in Healthy Adult Volunteers in 24 participants. Currently enrolling.

Timeline

25 November 2024

Primary endpoint
25 March 2025

5 May 2025

Quick facts

Lead sponsor	NIBEC Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	25 November 2024
Primary completion	25 March 2025
Estimated completion	5 May 2025
Sites	1 location across Australia

Drugs / interventions tested

NP-201 acetate injection (Part A) — full drug profile →
Placebo

Conditions studied

Healthy Adult Volunteers — all drugs for Healthy Adult Volunteers →
Active Ulcerative Colitis — all drugs for Active Ulcerative Colitis →
Active Ulcerative Colitis (UC) — all drugs for Active Ulcerative Colitis (UC) →

Sponsor

NIBEC Co., Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy Adult Volunteers or Active Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other NIBEC Co., Ltd. trials

Trials by the same sponsor.

NCT06783660 — PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06681389 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NIBEC Co., Ltd.
Last refreshed: 7 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06681389.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing