New pill for chronic hives enters first human safety tests
NCT ID NCT07540910
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests the safety of an experimental oral drug called EDP-978 in 98 healthy adults. Researchers will give single and multiple doses to see how the body handles it and whether it causes side effects. The drug is being developed for chronic hives, but this study does not test if it works—only if it is safe enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EDP-978
- What this could lead to
- If safe, this could lead to larger trials testing EDP-978 as a treatment for chronic hives.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only checks safety and dosing, not whether the drug works for hives.
Why investors are watching
Enanta Pharmaceuticals is testing EDP-978, an oral drug candidate, in a first-in-human phase 1 trial with 98 healthy adults. The study checks the drug's safety, how the body processes it, and its effects after single and multiple doses, plus how food changes its absorption. For a small company, this early readout is the first real test of whether EDP-978 is safe enough to keep developing.
If it works: If the trial shows EDP-978 is safe and well-tolerated, Enanta can move the drug into later-stage studies, which would validate its research pipeline and give the company a new asset to advance.
If it fails: Phase 1 trials often fail because the drug proves unsafe or has poor effects in people, even after promising lab results. A failure or delay would likely force Enanta to abandon EDP-978 and could hurt its prospects, since the company has few other public catalysts.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit * Pregnant or nursing females. * History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * A positive urine drug screen at screening or Day -1. * Current tobacco smokers or use of tobacco within 3 months prior to screening. * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * History of regular alcohol consumption. * Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ICON Early Phase
RECRUITINGSan Antonio, Texas, 78209, United States
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