Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI8111 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | MEDI8111 |
| B | PLACEBO_COMPARATOR | Placebo for MEDI8111 |
| Name | Type | Description |
|---|---|---|
| MEDI8111 | DRUG | MEDI8111 lyophilisate for solution for infusion |
| Placebo | OTHER | Placebo for MEDI8111 saline solution for infusion |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at lea...
MEDI8111 is a small molecule being developed by AstraZeneca PLC. It is currently in Phase 1 clinical development. The drug has been studied in a completed Phase 1 trial involving healthy subjects.
MEDI8111 has been investigated in healthy subjects, not in patients with a specific disease. The completed Phase 1 trial assessed the drug in healthy volunteers, so its therapeutic indication has not been established yet.
The Phase 1 trial, NCT01958645, was a single ascending dose study of intravenous MEDI8111. It was a placebo-controlled, randomized trial that was not double-blinded. The trial enrolled 157 healthy male participants aged 18 years and older in the United Kingdom.
No, there are no active trials for MEDI8111. The only trial, NCT01958645, has been completed. This Phase 1 study enrolled 157 participants and was conducted in the United Kingdom.
The clinical trial for MEDI8111, NCT01958645, has a status of completed. It was a Phase 1 study that assessed the safety, tolerability, and pharmacodynamics of single ascending doses of the drug administered intravenously.
Eligibility for the MEDI8111 trial was limited to healthy male volunteers aged 18 years and older. The trial was conducted in the United Kingdom and enrolled 157 participants. Healthy volunteers were accepted, and the study was not open to females.