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EDP-978 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 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 |
| EDP-978 MAD Cohorts | EXPERIMENTAL | EDP-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 | Matching placebo, orally, once daily in one single administration |
| EDP-978 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-978 | DRUG | Oral administration |
| Placebo | DRUG | Placebo to match EDP-978, oral administration |
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 i...
EDP-978 is an investigational small molecule being developed for chronic inducible urticaria, a type of chronic hives triggered by specific physical stimuli. It is also being studied in chronic spontaneous urticaria. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
EDP-978 targets KIT, a receptor tyrosine kinase involved in the activation and survival of mast cells. By inhibiting KIT, EDP-978 aims to reduce mast cell activity, which is central to the development of urticaria symptoms. This mechanism is being evaluated in early-stage clinical trials.
EDP-978 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the safety and efficacy of EDP-978 for chronic urticaria indications.
EDP-978 is in Phase 1 clinical development. The drug is investigational and has not received regulatory approval. It is currently being studied in a Phase 1 trial that is recruiting participants in the United States to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics.
EDP-978 is being studied in a Phase 1 clinical trial with the identifier NCT07540910. This randomized, double-blind, placebo-controlled study is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of EDP-978 in healthy adults. The trial is recruiting participants in the United States.
No alternative names for EDP-978 have been disclosed. The drug is identified solely by its development code EDP-978 and is being investigated by Enanta Pharmaceuticals for chronic urticaria conditions. It is a distinct small molecule candidate in early clinical development.