Phase 1 Haemophilia Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Part A (healthy volunteers):

• Men between 18 and 55 years old
• People with a body weight between 50 kg and 90 kg, and a body mass index (a measure of weight relative to height) between 18 and 30
• People with no significant health problems found during a medical check-up, heart tracing (ECG), or blood/urine tests
• Sexually active men who are willing to use effective contraception during the study and for 90 days after receiving the study treatment

Part B (people with bleeding disorders):

• Men and women between 18 and 60 years old (women are only eligible for Part B if they have a condition called congenital Factor VII deficiency, meaning they were born with it)
• People diagnosed with one of the following: severe haemophilia A (very low levels of clotting Factor VIII); severe or moderately severe haemophilia B (very low levels of clotting Factor IX); or severe Factor VII deficiency
• People with severe Factor VII deficiency who have had more than 2 bleeding episodes in the last 12 months needing treatment, or who are already receiving regular preventive treatment for this condition
• People with haemophilia A or B who have a recorded history of a certain number of bleeding events in the past 12 months, or who cannot tolerate their current treatment (confirm with trial site for exact numbers)
• People who have at least 2 years of medical records documenting their bleeding history
• People who are willing to temporarily pause their current treatment during a transition period before the study begins
• Sexually active men who are willing to use effective contraception during the study and for 90 days after receiving the study treatment
• Women who could become pregnant who have a negative pregnancy test at the screening visit and who agree to use contraception during the study and for at least 90 days after the last dose of study treatment

Who may not be able to join:

Part A:

• People with a significant history of heart, lung, liver, kidney, digestive, hormonal, nervous system, immune system, bleeding, or mental health conditions
• People whose heart rate, blood pressure, or heart electrical activity (measured on an ECG) falls outside specific normal ranges at screening
• People who have had an injury, significant trauma, or major surgery in the 3 months before screening, or who have surgery planned during the study
• People who have received a vaccine within 14 days before the study treatment dose, or who have a vaccination planned during the study
• People, or family members, with certain inherited blood-clotting conditions, including Factor V Leiden mutation, activated protein C resistance, Protein C or Protein S deficiency, Prothrombin 20210 mutation, or Antithrombin III deficiency
• People with a history of significant bleeding in the brain, pneumonia, chronic liver disease, liver or kidney transplants, or cancer
• People with any other medical condition that the study doctor believes could affect safety, interfere with how the study treatment works, or affect the reliability of the study results
• People with any history of blood clots of any kind, including clots in arteries or veins, superficial vein inflammation, embolism (a clot that has travelled through the body), stroke, mini-stroke (TIA), or abnormal results from previous clotting disorder tests

Part B:

• People with any history of blood clots of any kind, including clots in arteries or veins, superficial vein inflammation, embolism, stroke, mini-stroke (TIA), or abnormal results from previous clotting disorder tests
• People, or family members, with certain inherited blood-clotting conditions, including Factor V Leiden mutation, activated protein C resistance, Protein C or Protein S deficiency, Prothrombin 20210 mutation, or Antithrombin III deficiency
• People with significant heart problems, including poorly controlled heart failure, reduced heart pumping function, significant irregular heartbeat, abnormal heart electrical activity on an ECG (including a condition called Long QT Syndrome), or a heart attack or unstable chest pain within the past 3 months
• People with uncontrolled high blood pressure, or a history of a blood pressure crisis or blood pressure-related brain condition
• People with certain abnormal liver-related blood test results at screening (confirm specific values with trial site)
• People whose kidneys are not filtering blood efficiently enough, based on a specific calculation using blood test results at screening
• People who test positive for HIV
• People with an active hepatitis B infection (additional testing will determine this if an initial test is positive)
• People who test positive for active hepatitis C virus (confirmed by a specific type of blood test)
• People with severe chronic liver disease, or a history of liver or kidney transplants
• People who have had a significant injury, major surgery, or major dental procedure (such as a tooth extraction) within 4 weeks before the first dose of study treatment, or who have surgery planned during the study
• People with an active infection requiring antibiotic or antiviral treatment, or who have been in a serious infection state (sepsis), within 14 days before the first dose of study treatment
• People with any other medical condition that the study doctor believes could affect safety or interfere with how the study treatment works
• Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after the last dose of study treatment

Important: Always verify eligibility with the trial site directly before applying.