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- Title
Safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of marstacimab in Chinese participants with severe haemophilia.
- Authors
Sun, Xiaohong; Liu, Wei; Luo, Binyu; Ma, Dongwei; Kalluru, Hindu; Zhou, Yangmei; Li, Jin; Peng, Ao; Liu, Yuwang; Tong, Xin; Sun, Lei; Teeter, John; Raje, Sangeeta; Yang, Renchi
- Abstract
Blood samples for PK and PD analyses were taken pre-dose and 1, 4, 12, 24, 48 and 72 h post-dose and then at Days 7, 14, 21 and 28. Median (range) baseline TGA peak level (a key coagulation-related clinical biomarker) of 9.20 (4.9-45.3) nmol in Chinese participants with severe haemophilia was similar to that seen in non-Asian patients with haemophilia ( I n i = 26).[7] The treatment-related trends in all PD endpoints were similar to those seen in healthy White participants[6] and non-Asian participants with severe haemophilia following administration of a single 300 mg dose of marstacimab.[7] No participants had positive ADAs at baseline. For severe haemophilia A or B (factor VIII [FVIII] or IX [FIX] activity levels <1% of normal [<1 IU/dL]), the main prophylaxis treatment is standard clotting factor concentrates (CFCs). Samples were collected at baseline (pre-dose on Day 1); 1, 4 and 12 h post-dose on Day 1; 24 h post-dose (Day 2); 48 h post-dose (Day 3); 72 h post-dose (Day 4); and at Days 7, 14, 21 and 28.
- Subjects
CHINESE people; HEMOPHILIA; PHARMACOKINETICS; PHARMACODYNAMICS; THROMBIN; INTRAVENOUS immunoglobulins
- Publication
Haemophilia, 2023, Vol 29, Issue 4, p1155
- ISSN
1351-8216
- Publication type
Article
- DOI
10.1111/hae.14814