Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMP-110 · 2 trials · 1 indication
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Based on the occurrence of dose-limiting toxicities (through Day 14)
| Arm | Type | Description |
|---|---|---|
| Crossover Group 1 | EXPERIMENTAL | Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo |
| Crossover Group 2 | EXPERIMENTAL | Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week |
| AMP-110 | EXPERIMENTAL | Escalating doses of AMP-110 |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMP-110 | BIOLOGICAL | 2, 5, or 10 mg/kg |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Must be able to provide written informed consent * Body mass index 18.5 to 35.0 kg/m2 * Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria * Global Functional Class I, II, or III according to ACR 1991 revised criteria * ...
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AMP-110 is an investigational monoclonal antibody being developed for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with studies evaluating its safety, tolerability, pharmacokinetics, and clinical activity in adult patients with this condition.
AMP-110 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to assess the drug's potential in treating rheumatoid arthritis.
AMP-110 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with rheumatoid arthritis.
AMP-110 has completed two Phase 1 clinical trials: NCT01878123, which enrolled 26 participants, and NCT02277574, which enrolled 29 participants. Both trials were conducted in the United States and focused on assessing the safety, tolerability, pharmacokinetics, and clinical activity of AMP-110 in patients with rheumatoid arthritis.
No alternative names for AMP-110 have been disclosed. It is referred to solely as AMP-110 in clinical trial records and development documentation.