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A Phase 1 Ascending Dose Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Anemic Patients
Led by Ascentage Pharma Group Inc. · Updated on 2026-04-15
105
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating APG-5918, an oral drug, to study its safety, how it moves within the body, and its early effects in healthy adults and patients with anemia. This Phase 1 trial aims to find out if APG-5918 is safe and tolerable and to explore dosing levels that might be effective for anemia treatment. The study includes healthy volunteers and patients with anemia, including those with beta-thalassemia and related conditions. The trial has two parts. Part A randomly assigns healthy volunteers to receive a single dose of APG-5918 or a placebo in a double-blind manner, with dose levels increasing across up to seven groups. Part B involves an open-label, multi-dose approach where anemic patients receive daily APG-5918 for 84 days or until treatment end. The study monitors safety, tolerability, drug levels in the blood, and preliminary effects on hemoglobin. Participants will undergo assessments including blood tests to measure drug concentration and hemoglobin levels, and monitoring for any adverse events up to 7 days in Part A and 84 days or until treatment end in Part B. The trial includes physical exams, lab tests, and ECGs to ensure safety. Total participation duration varies, with regular visits to assess how well the drug is tolerated and its early effects on anemia.
CONDITIONS
Brief 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 between 18 and 28 kg/m² for healthy subjects
- Hemoglobin value from 120 g/L to 160 g/L for healthy subjects
- Normal body iron stores for healthy subjects
- Anemic patients aged 18 years or older
- Anemic patients with beta-thalassemia or related anemias and hemoglobin 100 g/L or less
- Body weight of 40 kg or more for anemic patients
- Serum folate and vitamin B12 levels above lower limit of normal
- Liver enzymes ALT and AST less than or equal to 2 times upper limit of normal
- No active or chronic bleeding
- ECOG performance status score of 0 or 1
- Negative pregnancy test for females of childbearing potential within 7 days before dosing
- Willingness to use effective contraception during treatment and for 3 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Healthy subjects with any disease or condition posing risk or confounding results
- ALT or AST greater than 2 times upper limit of normal or total bilirubin greater than 1.5 times upper limit of normal in healthy subjects
- Surgery within 3 months prior to screening (excluding minor procedures) in healthy subjects
- Blood loss or donation exceeding 400 mL within 3 months prior to screening or planned during study
- Use of investigational products within 30 days or 5 half-lives before dosing
- History of substance abuse within 6 months
- Positive alcohol breath test
- Anemic patients with uncontrolled autoimmune disease
- Severe cardiac or renal disease or dialysis dependence
- Active cancer, history of cancer, or familial cancer syndrome
- History of persistent hemolysis unrelated to study disease
- Recent thrombosis within 4 weeks prior to screening
- Intravenous iron supplementation within 28 days before dosing
- Active infection requiring systemic antibiotics within 14 days before dosing
- History of organ transplantation
- Conditions affecting drug absorption
- Use of cytotoxic agents, high-dose corticosteroids, immunosuppressants, or anticoagulants within 28 days before dosing
- Positive screening for hepatitis B, hepatitis C, HIV, or syphilis
- Regular alcohol consumption above defined limits within 6 months
- ECG with QTcB above 450 ms for males or 470 ms for females
- Female subjects pregnant, breastfeeding, or planning pregnancy; male subjects with partners planning pregnancy
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Healthy volunteers receive a single dose of APG-5918 or placebo to evaluate safety and pharmacokinetics.
1 dosing visit and follow-up visits up to 7 days
Duration - Up to 84 days or until end of treatment
Anemic patients receive once daily APG-5918 for up to 84 days or until end of treatment to evaluate safety, pharmacokinetics, and preliminary efficacy.
Daily dosing and visits on Days 1, 15, and 28 with additional safety assessments
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
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Research Team
Y
Yifan Zhai, Ph.D.
Z
Zhongyuan Xu
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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