Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDI048 · 1 trial · 1 indication
Number of participants with AEs and Serious Adverse Events (AEs), including significant changes from baseline in vital signs, electrocardiograms and laboratory assessments qualifying and reported as AEs.
| Arm | Type | Description |
|---|---|---|
| Part A: EDI048 or Placebo | EXPERIMENTAL | Part A is a single ascending dose study |
| Part B: EDI048 or Placebo | EXPERIMENTAL | Part B is a multiple ascending dose study |
| Name | Type | Description |
|---|---|---|
| EDI048 | DRUG | Oral Liquid |
| Placebo | OTHER | Oral Liquid |
Inclusion Criteria: * Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Participants must weigh at least 50 kg to participate in th...
EDI048 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed first-in-human trial assessing its safety, tolerability, and pharmacokinetics. EDI048 is not approved for any indication and remains under investigation.
EDI048 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.
EDI048 is in Phase 1 clinical development. A first-in-human study, NCT05275855, has been completed, evaluating the safety, tolerability, and pharmacokinetics of EDI048 in 110 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
EDI048 has one completed clinical trial, NCT05275855, titled "First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers." This Phase 1 study enrolled 110 participants in the United Kingdom and was randomized, double-blind, and controlled.
EDI048 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed first-in-human trial, NCT05275855, has evaluated its safety and pharmacokinetics in healthy volunteers, but it has not been approved for any medical use.