A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EDP-978, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug EDP-978
Oral administration - Drug Placebo
Placebo to match EDP-978, oral administration
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- ICON Early Phase — San Antonio
Identifiers
NCT: NCT07540910 · EDP 978-001