Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 282 · 2 trials · 2 indications
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Subject incidence of anti-AMG 282 antibodies
| Arm | Type | Description |
|---|---|---|
| AMG 282 | EXPERIMENTAL | AMG 282 administered as subcutaneous and intravenous doses. |
| Placebo | PLACEBO_COMPARATOR | No active drug |
| Experimental Arm | ACTIVE_COMPARATOR | - |
| Placebo Arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 282 | DRUG | AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps |
| Placebo | DRUG | Contains no active drug |
| AMG 282 Matching Placebo | DRUG | Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1. |
Healthy Volunteers: Inclusion Criteria: * Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive Exclusion Criteria: * subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation,...
AMG 282 is an investigational small molecule being studied for asthma and chronic rhinosinusitis with nasal polyps. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in clinical trials.
AMG 282 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical development for respiratory conditions including asthma and chronic rhinosinusitis with nasal polyps.
AMG 282 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in healthy subjects and subjects with mild atopic asthma, and another in healthy subjects and subjects with chronic rhinosinusitis with nasal polyps.
AMG 282 has completed two Phase 1 clinical trials. NCT01928368 was a first-in-human, double-blind, single-dose study in healthy subjects and subjects with mild atopic asthma, enrolling 70 participants. NCT02170337 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects and subjects with chronic rhinosinusitis with nasal polyps, enrolling 41 participants.
AMG 282 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed early-stage trials for asthma and chronic rhinosinusitis with nasal polyps, but it remains under investigation and has not been authorized for commercial use.