A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Anemia

In brief

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.

Key facts

Study ID

NCT05773586

Run by

Ascentage Pharma Group Inc.

People needed

105

Starts

2023-03-13

Expected to finish

2028-07-15

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Subjects:
• 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:
• Age: ≥ 18 years.
• Including beta-thalassemia and other related anemias, with screening Hb ≤ 100.0 g/L.
• Body weight ≥ 40 kg.
• Serum folate and vitamin B12 levels above the lower limit of normal (LLN).
• ALT, AST ≤ 2×ULN, and direct (unconjugated) total bilirubin (DBIL) ≤ 2×ULN. Higher levels may be accepted after excluding other diseases based on investigator judgment.
• No active or chronic bleeding.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• For female subjects of childbearing potential, a negative blood or urine pregnancy test within 7 days prior to the first dose.
• Subjects and their partners must voluntarily agree to use effective contraceptive measures as required by the protocol during the treatment period and for at least 3 months after the last dose of study drug.
• Ability to understand and voluntarily sign a written informed consent form, which must be signed before any trial-specific procedures are performed.
• Exclusion Criteria -
• Healthy Subjects:
• History of any disease or clinical condition that, in the investigator's opinion, may confound the study results or pose additional risk to the subject with administration of the study drug.
• ALT or AST > 2×ULN, or TBIL > 1.5×ULN at screening.
• Undergone surgery (excluding minor cosmetic or dental procedures) within 3 months prior to screening.
• Blood donation or blood loss exceeding 400 mL within 3 months prior to screening, or planned donation of blood or blood components during the study period.
• Use of another investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing, or current participation in a prospective study of an investigational product or medical device.
• History of substance abuse within 6 months prior to screening.
• Positive alcohol breath test.
• Anemic Subjects:
• Presence of clinically significant or uncontrolled ongoing autoimmune disease.
• Severe cardiac disease.
• Severe renal disease, defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m², or dependence on dialysis.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.