A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEquilibra Bioscience LLC

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SR604
  • Placebo

Treatment groups

31 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators