NCT04676178 is a Phase 1 clinical trial of PRA023 in Healthy, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT04676178?

Interventions in NCT04676178: PRA023, Placebo.

Is NCT04676178 still recruiting?

NCT04676178 is currently completed. Last updated 17 January 2024.

Last reviewed 2024-01-17 · How we verify

NCT04676178

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

A Study of PRA023 in Healthy Volunteers

Completed Phase 1 Last updated 17 January 2024

What this trial tests

Phase 1 trial testing PRA023 in Healthy in 69 participants. Completed in 23 September 2021.

Timeline

15 December 2020

Primary endpoint
23 September 2021

23 September 2021

Quick facts

Lead sponsor	Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	69
Start date	15 December 2020
Primary completion	23 September 2021
Estimated completion	23 September 2021
Sites	1 location across United States

Drugs / interventions tested

PRA023 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

TNF superfamily control of tissue remodeling and fibrosis.
Steele H, Cheng J, Willicut A, Dell G, et al · · 2023 · cited 50× · PMID 37465675 · DOI 10.3389/fimmu.2023.1219907
The Therapeutic Potential of Targeting TL1A in a Spectrum of Inflammatory Disorders.
Kitsou K, Kokkotis G, Bamias G. · · 2026 · PMID 41867469 · DOI 10.2147/jir.s546272

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

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NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials

Trials by the same sponsor.

NCT05603182 — A Study of PRA052 in Healthy Volunteers · Phase 1 · completed
NCT05354349 — Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023 · Phase 1 · completed
NCT05270668 — Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With I · Phase 2 · active not recruiting
NCT05013905 — A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease · Phase 2 · completed
NCT04996797 — A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulce · Phase 2 · completed

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 NCT04676178 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 17 January 2024

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/NCT04676178.

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