Chronic Inducible UrticariaPhase 1NCT07540910
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
A Phase 1 study testing EDP-978 in people with Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
- What is being tested?
- EDP-978
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ICON Early Phase
San Antonio, Texas, 78209
Shannon Kirk, Shannon.Kirk@iconplc.com
Shannon, 9134102258, shannon.kirk@iconplc.com
About this study
Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants
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.
- Being tested
- EDP-978, Placebo
- Keywords
- First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Participant
- Medical subject headings
- Chronic Inducible Urticaria, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-978Drug
Oral administration
PlaceboDrug
Placebo to match EDP-978, oral administration
| Study group | Role | What they receive |
|---|---|---|
| EDP-978 SAD Cohorts | Experimental | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration Receives: Drug: EDP-978 |
| EDP-978 MAD Cohorts | Experimental | EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days Receives: Drug: EDP-978 |
| EDP-978 SAD Placebo Cohorts | Placebo comparator | Matching placebo, orally, once daily in one single administration Receives: Drug: Placebo |
| EDP-978 MAD Placebo Cohorts | Placebo comparator | Matching placebo, orally, once daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by adverse events
Measured: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Measured: Up to 28 Days in MAD Cohorts
Secondary outcomes (6)
Cmax of EDP-978
Measured: Up to 5 Days in SAD Cohorts
AUC of EDP-978
Measured: Up to 5 Days in SAD Cohorts
Cmax of EDP-978
Measured: Up to 18 Days in MAD Cohorts
AUC of EDP-978
Measured: Up to 18 Days in MAD Cohorts
Cmax of EDP-938 (FE)
Food effects on plasma PK parameters of EDP-978
Measured: Up to 12 Days in FE SAD Cohort
AUC of EDP-938 (FE)
Food effects on plasma PK parameters of EDP-978
Measured: Up to 12 Days in FE SAD Cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inducible UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540910
- Sponsor's protocol ID
- EDP 978-001
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07540910
- Acronym / sponsor ID
- EDP 978-001
- Keywords
- First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Participant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EDP-978 SAD Cohorts | Experimental | Drug: EDP-978EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration |
| EDP-978 MAD Cohorts | Experimental | Drug: EDP-978EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days |
| EDP-978 SAD Placebo Cohorts | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily in one single administration |
| EDP-978 MAD Placebo Cohorts | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-978Oral administration | Drug | EDP-978 MAD Cohorts, EDP-978 SAD Cohorts |
| PlaceboPlacebo to match EDP-978, oral administration | Drug | EDP-978 MAD Placebo Cohorts, EDP-978 SAD Placebo Cohorts |
Primary outcome
Safety measured by adverse events
Time frame: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 28 Days in MAD Cohorts
6 secondary outcomes
Cmax of EDP-978
Time frame: Up to 5 Days in SAD Cohorts
AUC of EDP-978
Time frame: Up to 5 Days in SAD Cohorts
Cmax of EDP-978
Time frame: Up to 18 Days in MAD Cohorts
AUC of EDP-978
Time frame: Up to 18 Days in MAD Cohorts
Cmax of EDP-938 (FE)
Time frame: Up to 12 Days in FE SAD Cohort
AUC of EDP-938 (FE)
Time frame: Up to 12 Days in FE SAD Cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Inducible Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
Enrolling by invitationPhase 2
Apremilast Added to Antihistamines in Chronic Urticaria
Chronic Urticaria, Chronic Spontaneous Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP-978 in people with Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enanta Pharmaceuticals, Inc ((617) 607-0800, emartin@enanta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by adverse events (time frame: Up to 8 Days in SAD Cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.