98 Participants NeededMy employer runs this trial

EDP-978 for Chronic Urticaria

EP
Overseen ByEnanta Pharmaceuticals, Inc
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Enanta Pharmaceuticals, Inc

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, EDP-978, to determine its safety and tolerability in treating chronic urticaria, a condition causing frequent hives or itchy welts. Participants will take either the medicine or a placebo (a pill with no active drug) to compare effects. Eligible participants should be healthy adults without a history of serious illnesses or infections. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have a positive drug screen or have taken an investigational agent recently.

Is there any evidence suggesting that EDP-978 is likely to be safe for humans?

Research has shown that EDP-978 is a new pill under development to treat chronic urticaria, a condition that causes hives and itching. This treatment works by blocking a part of the immune system involved in these symptoms.

Although no data from human trials exists yet, early studies in labs and animals have shown promising results. In these studies, EDP-978 reduced certain cell activities linked to urticaria, suggesting it could be effective and possibly safe.

EDP-978 is currently in the early stages of human testing, known as Phase 1. The main goal at this stage is to assess its safety and how well people can tolerate it. Researchers are administering the treatment to healthy volunteers to monitor for any side effects.

When a treatment reaches Phase 1 trials, earlier research usually suggests it might be safe for humans. However, more information from ongoing studies is needed to fully understand its safety in people.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about EDP-978 for chronic urticaria because it offers a novel approach different from standard treatments like antihistamines and biologics. Unlike these existing options, which primarily manage symptoms, EDP-978 may target underlying pathways more effectively. This oral medication has multiple dosing options, potentially allowing for tailored treatment plans to better address individual patient needs. By exploring various dosing regimens, EDP-978 aims to provide faster and more sustained relief, enhancing quality of life for those with chronic urticaria.

What evidence suggests that EDP-978 might be an effective treatment for chronic urticaria?

Research has shown that EDP-978 could be a promising treatment for chronic urticaria, a condition that causes itchy hives or swelling. This trial will evaluate EDP-978 in different dosing regimens. EDP-978 blocks the KIT receptor, which plays a role in the allergic reactions causing these symptoms. Early studies found that EDP-978 is highly effective, working well even in small amounts. It also demonstrated strong results in live tests and showed high selectivity, targeting the right cells without significantly affecting others. These early findings suggest that EDP-978 could be a good option for people with chronic urticaria.12356

Who Is on the Research Team?

EP

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18 to 65 who are willing to give informed consent. Participants should not have any significant health problems.

Inclusion Criteria

* An informed consent document signed and dated by the subject.
I am healthy and between 18 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive single ascending doses of EDP-978 or placebo

1 day per dose
1 visit per dose (in-person)

Multiple Ascending Dose (MAD) Treatment

Participants receive multiple ascending doses of EDP-978 or placebo for 14 days

14 days
Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EDP-978

Trial Overview

The study tests different single and multiple oral doses of a new drug, EDP-978, compared to a placebo. It aims to see how safe the drug is, how well people tolerate it, and how the body processes it in healthy adults.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: EDP-978 SAD CohortsExperimental Treatment1 Intervention
Group II: EDP-978 MAD CohortsExperimental Treatment1 Intervention
Group III: EDP-978 SAD Placebo CohortsPlacebo Group1 Intervention
Group IV: EDP-978 MAD Placebo CohortsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials
42
Recruited
3,200+

Citations

NCT07540910 | A Study to Investigate the Safety, ...

It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult ...

Enanta Pharmaceuticals Announces First Participant ...

EDP-978 is a novel, potent and selective oral KIT inhibitor in development for the treatment of chronic urticaria and potentially other mast ...

Enanta Pharmaceuticals to Present Preclinical Data for EDP ...

Enanta Pharmaceuticals to Present Preclinical Data for EDP-978, its KIT Inhibitor in Development for the Treatment of Type 2 Immune Diseases, at the 2026 AAAAI ...

EDP-978 for Chronic Urticaria

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics ...

Enanta Pharmaceuticals Announces First Participant ...

EDP-978 demonstrates nanomolar potency in both binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus ...

Enanta Starts Phase 1 Trial for EDP-978

By targeting KIT, a key driver in mast cell activity, EDP-978 has the potential to address underlying mechanisms of diseases such as urticaria.