AnemiaPhase 1NCT05773586
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.
A Phase 1 study testing APG-5918 in people with Anemia, run by Ascentage Pharma Group Inc. at 2 sites in China.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- APG-5918
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesChina
- Study dates
- 13 Mar 2023to 15 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects:
- 1. 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).
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- 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.
- 3. For female subjects of childbearing potential, a negative blood or urine pregnancy test within 7 days prior to the first dose.
- 4. 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.
- 5. Ability to understand and voluntarily sign a written informed consent form, which must be signed before any trial-specific procedures are performed.
Who cannot join
- 1. 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.
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- History of substance abuse within 6 months prior to screening.
- Positive alcohol breath test.
- 2. 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.
- Active malignancy, history of cancer, or presence of a known or suspected familial cancer syndrome in linealrelatives.
- A history of persistent hemolysis or hemolytic syndrome due to causes other than the study diseases.
- A history of thrombosis or newly developed thrombus within 4 weeks prior to screening.
- Receipt of intravenous iron supplementation within 28 days prior to first dosing.
- Any active infection requiring systemic antibiotic therapy (including oral, intravenous, or intraperitoneal administration) within 14 days prior to first dosing.
- A history of organ transplantation.
- Any condition that may affect drug absorption.
- Participation in another clinical study and still using another investigational products, or without completion of a washout period of at least 5 half-lives within 4 weeks prior to first dosing.
- Receipt of cytotoxic agents, high-dose systemic corticosteroids, immunosuppressive agents, or anticoagulant therapy such as warfarin within 28 days prior to first dosing.
- 3. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody at screening.
- 4. A history of regular alcohol consumption within 6 months prior to screening, defined as an average daily intake of ≥30 grams (for males) or ≥20 grams (for females) of ethanol.
- 5. Standard 12-lead ECG with QTcB > 450 ms for males or QTcB > 470 ms for females.
- 6. Female subjects who are pregnant, planning to become pregnant, or breastfeeding; or male subjects whose partners are planning to become pregnant.
- 7. Any subject deemed unsuitable for participation in this study based on the investigator's judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Yang Liang, M.D.,Ph.D.
Yang Liang, M.D.,Ph.D.
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhongyuan Xu, M.D.,Ph.D., 020-62787926
Zhongyuan Xu, M.D.,Ph.D.
About this study
Official title: A Phase 1, Ascending Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Patients With Anemia.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
Read the detailed description
The trial is composed of ttwo parts. Part A is a randomized, double-blind, placebo- controlled, single-dose escalation study in up to 7 cohorts to evaluate the safety, tolerability, and PK characteristics of APG-5918 in healthy volunteers and to explore whether MTDS will be achieved within the range of projected therapeutic doses for anemia.
Part B is an open-label,, multi-dose escalation trial in up to 6 cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of APG-5918 in patients with anemia.
- Conditions
- Anemia
- Being tested
- APG-5918, Placebo
- Keywords
- APG-5918, Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-5918Drug
oral tablets 10mg, 50mg, 200mg.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) | Experimental | Subjects will be randomized to receive a single dose of APG-5918 or placebo. Receives: Drug: APG-5918; Drug: Placebo |
| Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B) | Experimental | Subjects will receive once daily APG-5918 for 84 days or till EOT. Receives: Drug: APG-5918 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be assessed via CTCAE version 5.0 based on the frequency of adverse events/serious adverse events (AEs/SAEs), clinically significant laboratory test results, 12-lead ECGs, and vital signs.
Measured: up to 7 days in Part A and 84 days or till EOT in Part B
Secondary outcomes (2)
Plasma Concentrations of APG-5918
Blood samples will be collected to measure the plasma concentration of APG-5918 by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method.
Measured: Days 1, 2 and 3 in Part A; Days 1, 15 and 28 in Part B
Measurement of Hemoglobin
Change from baseline in hemoglobin will be measured in peripheral whole blood by flow cytometry.
Measured: 84 days or till EOT in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start13 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongyuan Xu, M.D.,Ph.D., Principal investigator, Nanfang Hospital, Southern Medical UniversityYang Liang, M.D.,Ph.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773586
- Sponsor's protocol ID
- APG5918AC101
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Ascending Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Patients With Anemia.
- ClinicalTrials.gov ID
- NCT05773586
- Acronym / sponsor ID
- APG5918AC101
- Conditions
- Anemia
- Keywords
- APG-5918, Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
Detailed description
The trial is composed of ttwo parts. Part A is a randomized, double-blind, placebo- controlled, single-dose escalation study in up to 7 cohorts to evaluate the safety, tolerability, and PK characteristics of APG-5918 in healthy volunteers and to explore whether MTDS will be achieved within the range of projected therapeutic doses for anemia.
Part B is an open-label,, multi-dose escalation trial in up to 6 cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of APG-5918 in patients with anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) | Experimental | Drug: APG-5918, Drug: PlaceboSubjects will be randomized to receive a single dose of APG-5918 or placebo. |
| Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B) | Experimental | Drug: APG-5918Subjects will receive once daily APG-5918 for 84 days or till EOT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy Subjects:
- 1. 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-5918oral tablets 10mg, 50mg, 200mg. | Drug | Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B), Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) |
| PlaceboMatching placebo | Drug | Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A) |
Primary outcome
Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 7 days in Part A and 84 days or till EOT in Part B
TEAEs will be assessed via CTCAE version 5.0 based on the frequency of adverse events/serious adverse events (AEs/SAEs), clinically significant laboratory test results, 12-lead ECGs, and vital signs.
2 secondary outcomes
Plasma Concentrations of APG-5918
Time frame: Days 1, 2 and 3 in Part A; Days 1, 15 and 28 in Part B
Measurement of Hemoglobin
Time frame: 84 days or till EOT in Part B
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongyuan Xu, M.D.,Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
Yang Liang, M.D.,Ph.D. principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APG-5918 in people with Anemia, run by Ascentage Pharma Group Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai, Ph.D. (+86-20-28069260, yzhai@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (TEAEs) (time frame: up to 7 days in Part A and 84 days or till EOT in Part B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.