Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05275855 | First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers | PHASE1 | COMPLETED | 110 | — | — | Apr 29, 2022 | Dec 18, 2024 | Jan 10, 2025 | 1 | United Kingdom |
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...