A Phase 1 Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary of APG-5918 in Healthy Subjects or Anemic Patients
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
‣ \-
• Inclusion criteria for healthy subjects
⁃ Age ≥ 18 years and ≤ 55 years.
⁃ Body mass index (BMI) 18\
‣ 28kg/m² (inclusive).
⁃ Hb: 120 g/L\
‣ 160 g/L (inclusive).
⁃ Normal iron stores (normal serum iron and serum ferritin).
• Inclusion criteria for anemic subjects
⁃ Age ≥ 18 years.
⁃ Chronic patients with anemia, including but not limited to β-thalassemia, with Hb ≤ 100 g/L at screening.
⁃ BMI: 16\
‣ 32 kg/m2 (inclusive).
⁃ Serum folate and vitamin B12 levels above lower limit of normal (LLN).
⁃ Ferritin ≥ 40 ng/mL.
⁃ ALT, AST ≤ 2 × ULN, or Direct (Unbound) total bilirubin (DBIL) ≤ 2.0× ULN.
⁃ No active or chronic bleeding.
⁃ ECOG performance status score of 0 to 1.
‣ 3\. Female subjects of childbearing potential who have a negative serum or urine pregnancy test within 7 days prior to the first dose.
‣ 4\. Subjects and their partners volunteer to use protocol-specified effective contraception during treatment and for at least 3 months after the last dose of study drug (see Section 8.7 for details).
‣ 5\. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).