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EDP-978 Phase 1 Study in Healthy Adults, Chronic Urticaria

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Summary

A Phase 1 clinical trial for EDP-978, an oral drug candidate for Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, has been registered on ClinicalTrials.gov. The randomized, double-blind, placebo-controlled study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses in healthy adult subjects.

“This study is a randomized, double-blind, sponsor-open, placebo-controlled study.”

NIH , verbatim from source
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What changed

EDP-978, an oral drug candidate, has entered Phase 1 clinical development for chronic urticaria indications. The trial will evaluate single and multiple doses in healthy adults. This is a study registration entry in the ClinicalTrials.gov registry — it does not create compliance obligations or regulatory approvals.

Pharmaceutical companies and clinical investigators interested in urticaria therapeutics may use this registry entry to identify ongoing competitive trials or potential collaboration opportunities. Sponsors of competing urticaria programs should monitor Phase 1 results for EDP-978 as the development progresses.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

Phase 1 NCT07540910 Kind: PHASE1 Apr 21, 2026

Abstract

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.

Conditions: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria

Interventions: EDP-978, Placebo

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07540910

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug development Pharmacology research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Public Health Healthcare

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