The Safety and Tolerability of SerpinPC in Healthy Men and in Men With Severe Blood Disorders (Haemophilia A and B)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 52
Summary
- Conditions
- Hemophilia A
- Hemophilia B
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study will be conducted in four parts (Part 1a, Part 1b, Part 2 and Part 3). Part 1a will be a single ascending dose study in 15 healthy male subjects. Part 1b will be a single ascending dose study in a minimum of 12 male patients with severe hemophilia A or B with or without inhibitors. Part 2 will be a multiple dose study in 20 to 25 male patients with severe hemophilia A or B with or without inhibitors. Part 3 will be an extension study of one dose level in up to 25 male patients who have completed Week 24 of Part 2. Subjects will be enrolled into cohorts in a sequential manner.Masking: Single (Participant)Masking Description: Part 1a: Open label for intravenous (IV) doses and single blinded for subcutaneous (SC) doses (subjects are blinded) Part 1b: Single blinded (patients are blinded) Part 2: Open label Part 3: Open labelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04073498
- Collaborators
- Not Provided
- Investigators
- Not Provided
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