Actively Recruiting
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.
Led by Ascentage Pharma Group Inc. · Updated on 2026-04-15
105
Participants Needed
2
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subjects aged 18 to 55 years
- Body mass index (BMI) between 18 and 28 kg/m2
- Hemoglobin between 120 and 160 g/L
- Normal body iron stores
- Anemic subjects aged 18 years or older
- Diagnosed with beta-thalassemia or related anemias with hemoglobin 4100 g/L
- Body weight at least 40 kg
- Serum folate and vitamin B12 levels above lower limit of normal
- Liver enzymes ALT and AST less than or equal to twice the upper limit of normal and direct bilirubin less than or equal to twice the upper limit of normal, with higher levels allowed after evaluation
- No active or chronic bleeding
- ECOG performance status score of 0-1
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Agreement to use effective contraception during treatment and for at least 3 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- History of any disease or condition that could affect study results or increase risk
- Elevated liver enzymes ALT or AST greater than twice the upper limit of normal or total bilirubin greater than 1.5 times the upper limit at screening
- Surgery within 3 months prior to screening (excluding minor cosmetic or dental procedures)
- Blood donation or loss exceeding 400 mL within 3 months prior to screening or planned donation during study
- Use of another investigational product within 30 days or 5 half-lives before dosing
- History of substance abuse within 6 months prior to screening
- Positive alcohol breath test
- Clinically significant or uncontrolled autoimmune disease
- Severe cardiac disease
- Severe renal disease or dialysis dependence
- Active malignancy, history of cancer, or familial cancer syndrome
- History of persistent hemolysis unrelated to study diseases
- Recent thrombosis within 4 weeks prior to screening
- Intravenous iron supplementation within 28 days prior to dosing
- Active infection requiring systemic antibiotics within 14 days prior to dosing
- History of organ transplantation
- Conditions affecting drug absorption
- Participation in another clinical study with investigational products without sufficient washout
- Recent use of cytotoxic agents, high-dose corticosteroids, immunosuppressants, or anticoagulants within 28 days prior to dosing
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis at screening
- Regular alcohol consumption exceeding specified limits within 6 months prior to screening
- ECG abnormalities with prolonged QTc interval
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Any condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Y
Yifan Zhai, Ph.D.
CONTACT
Z
Zhongyuan Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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