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).
Male participants aged 18 to 55 years, inclusive.
Body mass index between 18 and 30 kilograms per meter square (kg/m²), 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.
Participant has clinically significant history or evidence of cardiovascular, respiratory (including all chronic lung diseases), hepatic, renal, gastrointestinal, endocrine, neurological, immunological, bleeding, or psychiatric disorder(s).
Participant has a mean pulse less than (<) 40 or greater than (>) 90 beats per minute (bpm), mean systolic blod pressure (BP) < 90 millimeter of mercury (mmHg) or > 140 mmHg, or mean diastolic BP < 50 mmHg or > 90 mmHg at the screening visit.
Participant has a mean corrected QT corrected for heart rate by Fridericia's formula (QTcF) of > 450 msec at the Screening Visit.
Participant has had injury, trauma, and/or major surgery within 3 months before Screening, or is planned to undergo surgery during the study.
Sequential
SR604
DrugSR604 will be administered as SC injection.
Placebo
DrugPlacebo will be administered as single SC injection.
8
Treatment groupsSee each treatment group below.
Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety and tolerability of a single ascending SC dose of SR604 in healthy participants and multiple ascending SC doses of SR604 in participants with Hemophilia A or Hemophilia B or FVII deficiency will be evaluated.
Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers
Safety and tolerability of a single ascending SC dose of SR604 in healthy participants and multiple ascending SC doses of SR604 in participants with Hemophilia A or Hemophilia B or FVII deficiency will be evaluated.
Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t])
The PK profile (AUC\[0-t\]) of a single ascending SC dose of SR604 in healthy participants will be assessed.
Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf])
The PK profile (AUC\[0-inf\]) of a single ascending SC dose of SR604 in healthy participants will be assessed.
Parts A and B: Maximum Concentration (Cmax) of SR604
The PK profile (Cmax) of a single ascending and multiple ascending SC dose of SR604 will be assessed.
Parts A and B: Time to Maximum Concentration (tmax) of SR604
The PK profile (tmax) of a single ascending and multiple ascending SC dose of SR604 will be assessed.
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