Equilibra Bioscience LLC
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B).
This is a first-in-human (FIH) study to be conducted with SR604. The study will enroll healthy participants (Part A) and participants with Hemophilia A or Hemophilia B or FVII deficiency (Part B). In Part A (single ascending dose \[SAD\]): Healthy participants will be randomized in a 2:1 ratio in each of the 3 to 4 (Cohort 4 is optional) sequential cohorts. All cohorts will include participants receiving active treatment with SR604 and the other participant receiving matching placebo. In Part B (multiple ascending dose \[MAD\]): Participants with Hemophilia A or Hemophilia B or FVII deficien…
Key Inclusion Criteria: Part A: * Male participants aged 18 to 55 years, inclusive. * Body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive, and weighs greater than or equal to (\>=) 50 kilograms (kg), less than or equal to (\<=) 90 kg. * No clinically significant findings on medical examination, including physical examination, 12-lead electrocardiogram, and clinical laboratory tests. * Sexually active men must commit to use an effective method of birth control while taking the study intervention and for 90 days after the dose of study intervention. Part B: * Ma…
SR604 will be administered as SC injection.
Placebo will be administered as single SC injection.