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About
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.
Full description
The trial has two 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 subjects and to explore whether MTDS will be achieved within the range of projected therapeutic doses for anemia.
Part B is an opened-label,, multi-dose escalation trial in up to 6 cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of APG-5918 in anemic subjects.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
1.Inclusion criteria for healthy subjects
2.Inclusion criteria for anemic subjects
Age ≥ 18 years.
Chronic patients with anemia, including but not limited to β-thalassemia, with Hb ≤ 100 g/L at screening.
BMI: 16~32 kg/m2 (inclusive).
Serum folate and vitamin B12 levels above lower limit of normal (LLN).
Ferritin ≥ 40 ng/mL.
ALT, AST ≤ 2 × ULN, or total bilirubin (TBIL) ≤ 3.0× ULN.
No active or chronic bleeding.
ECOG performance status score of 0 to 1.
Female subjects of childbearing potential who have a negative serum or urine pregnancy test within 7 days prior to the first dose.
Subjects and their partners volunteer to use protocol-specified effective contraception during treatment and for at least 3 months after the last dose of study drug (see Section 8.7 for details).
Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
Exclusion criteria
1.Exclusion criteria for healthy subjects
2.Exclusion criteria for anemic subjects
3.Positive screening results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus antibody (HIV Ab), or treponema pallidum antibody at screening.
4.Standard 12-lead ECG QTcB > 450 ms in men and > 470 ms in women. 5. History of regular alcohol consumption within 6 months before screening, daily average intake of ethanol ≥ 30 grams (male) or ≥ 20 grams (female).
Female subjects who are pregnant, planning to become pregnant, or breastfeeding, or male subjects whose partners intend to become pregnant.
Any subject who is not suitable for participating in this study as judged by the investigator.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 2 patient groups
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Central trial contact
Yifan Zhai, Ph.D.; Zhongyuan Xu
Data sourced from clinicaltrials.gov
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