A Study to Investigate the Safety, Pharmacokinetics and Efficacy of APG-5918 in Healthy Subjects or Anemic Patients

Launched by ASCENTAGE PHARMA GROUP INC. · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called APG-5918 for people with anemia, a condition where the body doesn’t have enough healthy red blood cells. The study aims to understand how safe the treatment is, how it works in the body, and whether it can effectively help patients with anemia. They are looking for participants who are either healthy adults aged 18 to 55 or adults aged 18 and older who have been diagnosed with anemia, including conditions like beta-thalassemia.

Participants in the trial can expect to undergo a screening process to determine if they meet the study's eligibility criteria, which includes having specific blood levels and health conditions. If selected, they will receive the treatment and will be monitored for any side effects and how their body responds to the medication. It’s important to note that participants should not have certain health issues, such as uncontrolled high blood pressure or recent infections, and women who can become pregnant will need to use effective contraception during the study. This trial is currently recruiting participants, and those interested should be willing to sign a consent form and follow the study guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -
• • 1.Inclusion criteria for healthy subjects
• • 1. Age ≥ 18 years and ≤ 55 years.
• • 2. Body mass index (BMI) 18\~28kg/m² (inclusive).
• • 3. Hb: 120 g/L\~160 g/L (inclusive).
• • 4. Normal iron stores (normal serum iron and serum ferritin).
• • 2.Inclusion criteria for anemic subjects
• • 1. Age ≥ 18 years.
• • 2. Chronic patients with anemia, including but not limited to β-thalassemia, with Hb ≤ 100 g/L at screening.
• • 3. BMI: 16\~32 kg/m2 (inclusive).
• • 4. Serum folate and vitamin B12 levels above lower limit of normal (LLN).
• • 5. Ferritin ≥ 40 ng/mL.
• • 6. ALT, AST ≤ 2 × ULN, or total bilirubin (TBIL) ≤ 3.0× ULN.
• • 7. No active or chronic bleeding.
• • 8. 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).
• • Exclusion criteria
• • 1.Exclusion criteria for healthy subjects
• • 1. History of any disease or clinical condition that, in the opinion of the investigator, could confound the results of the study or pose an additional risk to the subject by administering study drug. Including but not limited to history or presence of cardiac, endocrine, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other diseases.
• • 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × upper limit of normal (ULN), or total bilirubin (TBIL) \> 1.5 × ULN at screening.
• • 3. Surgery (except minor cosmetic surgery or minor dental surgery) within 3 months prior to screening.
• • 4. Blood donation or blood loss of more than 400 ml within 3 months before screening or plans to donate blood or blood components during the study.
• • 5. Use of another investigational product within 30 days or 5 half-lives, whichever is longer, or currently participating in a prospective study of an investigational product or medical device.
• • 6. History of addictive substance abuse.
• • 7. Alcohol breath test fails.
• • 2.Exclusion criteria for anemic subjects
• • 1. Clinically significant or uncontrolled persistent autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.).
• • 2. Uncontrolled hypertension (diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 170 mmHg at screening) or diabetes as judged by the investigator.
• • 3. New York Heart Association Class II to IV congestive heart failure, or recent myocardial infarction or acute coronary syndrome.
• • 4. History of diagnosis of persistent hemolysis or hemolytic syndrome except for beta-thalassemia.
• • 5. History of thrombosis or new blood clots within 4 weeks prior to screening.
• • 6. Any active infection requiring systemic antibiotics within 14 days prior to the first dose administration.
• • 7. Intravenous iron within 28 days prior to screening.
• • 8. Previous history of organ transplantation.
• • 9. Patients who participated in other clinical studies within 4 weeks prior to the first dose administration and were still taking other study drugs or had not exceeded 5 half-lives.
• • 3.Positive screening results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody (HIV Ab), or treponema pallidum antibody at screening.
• • 4.Standard 12-lead ECG QTcB \> 450 ms in men and \> 470 ms in women. 5. History of regular alcohol consumption within 6 months before screening, daily average intake of ethanol ≥ 30 grams (male) or ≥ 20 grams (female).
• • 6. Female subjects who are pregnant, planning to become pregnant, or breastfeeding, or male subjects whose partners intend to become pregnant.
• • 7. Any subject who is not suitable for participating in this study as judged by the investigator.