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Tests treatment safety and results for Healthy Participants
Official title 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)
ClinicalTrials.gov ID: NCT06349473
What this study is testing
What is SR604?
SR604 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Key Part A:
- Male participants aged 18 to 55 years, inclusive.
- Body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive, and weighs greater than or equal to (\>=) 50 kilograms (kg), less...
- 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...
You likely can't join if
- Part A:
- Participant has clinically significant history or evidence of cardiovascular, respiratory (including all chronic lung diseases), hepatic, renal...
- Participant has a mean pulse less than (\ ) 90 beats per minute (bpm), mean systolic blod pressure (BP) \ 140 mmHg, or mean diastolic BP \ 90 mmHg at...
- 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.
- Participant has received vaccination within 14 days before the dose of study intervention or has a vaccination planned during the study.
See the full eligibility criteria
Who can join
- Key Part A:
- Male participants aged 18 to 55 years, inclusive.
- Body mass index between 18 and 30 kilograms per meter square (kg/m\^2), 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. Part B:
- Male and female participants (only female participants with congenital FVII deficiency) aged 18 to 60 years, inclusive.
- Participants must have one of the following bleeding disorders: Severe hemophilia A (\<1% Factor VIII [FVIII]); or Severe and/or moderately severe Hemophilia B (≤ 2% Factor IX [FIX]); or Severe FVII deficiency (\<10%...
- Participants with history of \>2 bleeding events in the last 12 months require on-demand treatment with recombinant factor VIIa (rFVIIa) or plasma-derived FVII concentrates (pd-FVII) or fresh frozen plasma (FFP) for...
- Participants on prophylaxis treatment with rFVIIa or pd-FVII or FFP regardless of bleeding history.
- Participants with Hemophilia A or Hemophilia B must satisfy either of the following criteria:
- Participants not on prophylaxis must have a documented ABR of 6 in 12 months before screening.
- Participants on prophylaxis must have a documented ABR of ≥ 2 in 12 months before screening.
- Intolerant to current treatment regimen.
- Medical records documenting a minimum of 2 years of bleeding event history.
- Willing to undergo a weaning period from prior treatment or prophylaxis for Hemophilia A or Hemophilia B or FVII deficiency.
- 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 SR604.
- Women of childbearing potential must have a negative pregnancy test at the Screening Visit and agree to follow the contraception guidance during the intervention period and for at least 90 days after the last dose of...
What rules you out
- Part A:
- Participant has clinically significant history or evidence of cardiovascular, respiratory (including all chronic lung diseases), hepatic, renal, gastrointestinal, endocrine, neurological, immunological, bleeding, or...
- Participant has a mean pulse less than (\ ) 90 beats per minute (bpm), mean systolic blod pressure (BP) \ 140 mmHg, or mean diastolic BP \ 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.
- Participant has received vaccination within 14 days before the dose of study intervention or has a vaccination planned during the study.
- History of one or more of the following in participants and/or family members:
- Factor V (FV) Leiden mutation.
- Activated protein C (APC) resistant.
- Protein C (PC) or protein S (PS) deficiency.
- Prothrombin 20210 mutation;
- Antithrombin III (ATIII) deficiency.
- History of clinically significant intracranial hemorrhage, pneumonia, chronic liver disease, liver or kidney transplants, or malignant diseases.
- Any medical condition (eg, diabetes, obesity.) which, in the Investigator's opinion, could compromise participant safety, interfere with study intervention metabolism, or put the study outcome at undue risk. Any...
- Participants with a history of all types of thrombosis, including any arterial and/or venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic...
- Participants with a history of all types of thrombosis, including any arterial and/or venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic...
- History of one or more of the following in participants and/or family members:
- FV Leiden mutation.
- APC resistant.
- PC or PS deficiency.
- Prothrombin 20210 mutation.
- ATIII deficiency.
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association Grade \>=2), left ventricular ejection fraction \< 50% as determined by multiple...
- QTcF \> 450 ms ECG or congenital Long QT Syndrome at the Screening Visit.
- Acute myocardial infarction or unstable angina pectoris \< 3 months prior to study entry.
- Uncontrolled hypertension (systolic BP \> 150 mmHg and diastolic BP \> 100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
- Participant with the following laboratory abnormalities:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 × upper limit of normal (ULN);
- Total bilirubin ˃3.0 × ULN and direct bilirubin ˃1.5 × ULN (unless due to Gilbert's syndrome).
- Calculated creatinine clearance ˂ 60 mL/min using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.
- Participant has positive test result for human immunodeficiency virus (HIV) antibody.
- If participants test positive for hepatitis B core antibody (HBcAb), additional tests including hepatitis B surface antibody, hepatitis B surface antigen (HBsAg), and hepatitis B viral deoxyribonucleic acid (DNA)...
- Participants who test positive for hepatitis C virus antibody will be required to have a negative result for hepatitis C viral ribonucleic acid (RNA) PCR before enrollment. Individuals with positive results for...
- Chronic liver disease (Child-Pugh class C hepatic impairment), or history of liver or kidney transplants.
- Injury, trauma, and/or major surgery (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery), major dental procedures (extractions, etc.) within 4...
- Active infection requiring systemic antibiotic or antiviral therapy or in a sepsis condition within 14 days prior to the first dose of SR604.
- Any medical condition (eg, diabetes, obesity) which, in the Investigator's opinion, could compromise participant safety, interfere with SR604 metabolism, or put the study outcome at undue risk.
- Female participants who are pregnant or are currently breastfeeding or planning to become pregnant while enrolled in this study or within 90 days after the last dose of SR604.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Metairie, Louisiana, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Greenville, North Carolina, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Los Angeles, California, United States; Chicago, Illinois, United States; Metairie, Louisiana, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.