A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.
ConditionAnemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
APG-5918
Drugoral tablets 10mg, 50mg, 200mg.
Placebo
DrugMatching placebo
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A)Experimental treatment 2 interventions
Group B: Multiple Ascending Dose (MAD) cohorts in Anemic Patients (Part B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 7 days in Part A and 84 days or till EOT in Part BSecondary outcomes
1
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.
Time frame
Days 1, 2 and 3 in Part A; Days 1, 15 and 28 in Part B2
Measurement of Hemoglobin
Change from baseline in hemoglobin will be measured in peripheral whole blood by flow cytometry.
Time frame
84 days or till EOT in Part BOther outcomes
1
Expression levels of H3K27me3
Expression levels of H3K27me3 in circulating monocytes will be evaluated by fluorescence-activated cell sorting (FACS).
Time frame
84 days or till EOT in Part BSponsors and contacts
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Source ClinicalTrials.gov