NCT07540910 A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
| NCT ID | NCT07540910 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Enanta Pharmaceuticals, Inc |
| Condition | Chronic Inducible Urticaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 98 participants in total. It began in 2026-04-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Enanta Pharmaceuticals, Inc
STUDY DIRECTOR
Enanta Pharmaceuticals, Inc
Frequently Asked Questions
Who can join the NCT07540910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Inducible Urticaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07540910 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07540910 currently recruiting?
Yes, NCT07540910 is actively recruiting participants. Contact the research team at emartin@enanta.com for enrollment information.
Where is the NCT07540910 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT07540910 clinical trial?
NCT07540910 is sponsored by Enanta Pharmaceuticals, Inc. The principal investigator is Enanta Pharmaceuticals, Inc at Enanta Pharmaceuticals, Inc. The trial plans to enroll 98 participants.