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
Qualifiers
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
Treatments tested in this trial
- APG-5918
- Placebo
Treatment groups
105 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov