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APG-5918 · 1 trial · 1 indication
TEAEs will be assessed via CTCAE version 5.0 based on the frequency of adverse events/serious adverse events (AEs/SAEs), clinically significant laboratory test results, 12-lead ECGs, and vital signs.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) | EXPERIMENTAL | Subjects will be randomized to receive a single dose of APG-5918 or placebo. |
| Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B) | EXPERIMENTAL | Subjects will receive once daily APG-5918 for 84 days or till EOT. |
| Name | Type | Description |
|---|---|---|
| APG-5918 | DRUG | oral tablets 10mg, 50mg, 200mg. |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: 1. Healthy Subjects: 1\. Age: 18 to 55 years. 2. Body Mass Index (BMI): 18-28 kg/m² (inclusive). 3. Hemoglobin value: 120 g/L-160 g/L (inclusive). 4. Normal body iron stores. 2. Anemic Subjects: 1. Age: ≥ 18 years. 2. Including beta-thalassemia and other related anemias, with ...
APG-5918 is an investigational small molecule being developed for the treatment of anemia. It is currently in Phase 1 clinical development, with an active trial evaluating its safety, pharmacokinetics, and preliminary efficacy in patients with anemia.
APG-5918 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting a Phase 1 clinical trial for this investigational anemia treatment.
APG-5918 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to evaluate its safety and preliminary efficacy.
APG-5918 is being studied in a Phase 1 clinical trial with the identifier NCT05773586. This randomized, double-blind, controlled study is recruiting 105 participants in China to evaluate the safety, pharmacokinetics, and preliminary efficacy of APG-5918 for anemia.
APG-5918 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to assess its safety and preliminary efficacy, and regulatory approval has not been granted.