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)

Study Identifier:
SR604-1
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Equilibra Bioscience LLC
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Unmapped
  • Hemophilia A
  • Hemophilia B
Study Drug
  • Drug: SR604
  • Drug: Placebo
Date
Apr 2024 - Apr 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 60 Years years
Requirements Information

Protocol Summary

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Locations

Location
Status
Location
California Clinical Trials Medical Group (CCTMG)
Glendale, California, United States, 91206
Status
Completed
Location
Rush University Medical Center
Chicago, Illinois, United States, 60612
Status
Not yet recruiting
Location
LA Center for Bleeding and Clotting Disorders - Metairie
Metairie, Louisiana, United States, 70001
Status
Recruiting
Location
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Status
Not yet recruiting
Location
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Status
Not yet recruiting
Location
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
Status
Not yet recruiting