[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"factor-vii-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:factor-vii-deficiency":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100542946","phase-1-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-100542946",false,"NCT06349473","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)","A Phase 1 Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency (Part B)","Key Inclusion Criteria:\n\nPart A:\n\n* Male participants aged 18 to 55 years, inclusive.\n* Body mass index between 18 and 30 kilograms per meter square (kg\u002Fm\\^2), inclusive, and weighs greater than or equal to (\\>=) 50 kilograms (kg), less than or equal to (\\\u003C=) 90 kg.\n* No clinically significant findings on medical examination, including physical examination, 12-lead electrocardiogram, and clinical laboratory tests.\n* 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.\n\nPart B:\n\n* Male and female participants (only female participants with congenital FVII deficiency) aged 18 to 60 years, inclusive.\n* Participants must have one of the following bleeding disorders: Severe hemophilia A (\\\u003C1% Factor VIII \\[FVIII\\]); or Severe and\u002For moderately severe Hemophilia B (≤ 2% Factor IX \\[FIX\\]); or Severe FVII deficiency (\\\u003C10% FVII activity). Participants with severe FVII deficiency must satisfy with either of following criteria:\n\n  1. 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 bleeding control.\n  2. Participants on prophylaxis treatment with rFVIIa or pd-FVII or FFP regardless of bleeding history.\n* Participants with Hemophilia A or Hemophilia B must satisfy either of the following criteria:\n\n  1. Participants not on prophylaxis must have a documented ABR of 6 in 12 months before screening.\n  2. Participants on prophylaxis must have a documented ABR of ≥ 2 in 12 months before screening.\n  3. Intolerant to current treatment regimen.\n* Medical records documenting a minimum of 2 years of bleeding event history.\n* Willing to undergo a weaning period from prior treatment or prophylaxis for Hemophilia A or Hemophilia B or FVII deficiency.\n* 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.\n* 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 SR604.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* 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).\n* Participant has a mean pulse less than (\\\u003C) 40 or greater than (\\>) 90 beats per minute (bpm), mean systolic blod pressure (BP) \\\u003C 90 millimeter of mercury (mmHg) or \\> 140 mmHg, or mean diastolic BP \\\u003C 50 mmHg or \\> 90 mmHg at the screening visit.\n* Participant has a mean corrected QT corrected for heart rate by Fridericia's formula (QTcF) of \\> 450 msec at the Screening Visit.\n* Participant has had injury, trauma, and\u002For major surgery within 3 months before Screening, or is planned to undergo surgery during the study.\n* Participant has received vaccination within 14 days before the dose of study intervention or has a vaccination planned during the study.\n* History of one or more of the following in participants and\u002For family members:\n\n  1. Factor V (FV) Leiden mutation.\n  2. Activated protein C (APC) resistant.\n  3. Protein C (PC) or protein S (PS) deficiency.\n  4. Prothrombin 20210 mutation;\n  5. Antithrombin III (ATIII) deficiency.\n* History of clinically significant intracranial hemorrhage, pneumonia, chronic liver disease, liver or kidney transplants, or malignant diseases.\n* 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 condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or could prevent, limit or confound protocol-specified assessments.\n* Participants with a history of all types of thrombosis, including any arterial and\u002For venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic microangiopathy, stroke, and transient ischemic attack (TIA), or abnormal findings in any prior laboratory thrombophilia evaluation will be excluded.\n\nPart B:\n\n* Participants with a history of all types of thrombosis, including any arterial and\u002For venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic microangiopathy, stroke, and TIA, or abnormal findings in any prior laboratory thrombophilia evaluation will be excluded.\n* History of one or more of the following in participants and\u002For family members:\n\n  1. FV Leiden mutation.\n  2. APC resistant.\n  3. PC or PS deficiency.\n  4. Prothrombin 20210 mutation.\n  5. ATIII deficiency.\n* Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n  1. Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association Grade \\>=2), left ventricular ejection fraction \\\u003C 50% as determined by multiple gated acquisition or echocardiogram, or clinically significant arrhythmia.\n  2. QTcF \\> 450 ms ECG or congenital Long QT Syndrome at the Screening Visit.\n  3. Acute myocardial infarction or unstable angina pectoris \\\u003C 3 months prior to study entry.\n* Uncontrolled hypertension (systolic BP \\> 150 mmHg and diastolic BP \\> 100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.\n* Participant with the following laboratory abnormalities:\n\n  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 1.5 × upper limit of normal (ULN);\n  2. Total bilirubin ˃3.0 × ULN and direct bilirubin ˃1.5 × ULN (unless due to Gilbert's syndrome).\n* Calculated creatinine clearance ˂ 60 mL\u002Fmin using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.\n* Participant has positive test result for human immunodeficiency virus (HIV) antibody.\n\n  1. 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) polymerase chain reaction (PCR) will be conducted to determine if there is an active infection. Participants with active infection will be excluded from the study.\n  2. 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 hepatitis C PCR will be excluded from the study.\n* Chronic liver disease (Child-Pugh class C hepatic impairment), or history of liver or kidney transplants.\n* Injury, trauma, and\u002For 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 weeks of the first dose of SR604 or planned surgery during the study.\n* Active infection requiring systemic antibiotic or antiviral therapy or in a sepsis condition within 14 days prior to the first dose of SR604.\n* 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.\n* 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.",true,"ALL","18 Years","60 Years",{"count":21,"type":22},31,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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).",[28,29,30,31],"Healthy Participants","Hemophilia A","Hemophilia B","Factor VII Deficiency",[33,34,35,36,37],"Single ascending dose","Multiple ascending dose","Factor IX","Factor VIII","Factor VII","RECRUITING","2026-06-30",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2024-05-10",{"date":46,"type":22},"2026-09-28",{"name":48,"class":49},"Equilibra Bioscience LLC","INDUSTRY",10,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100641949","phase-1-an-open-label-multicenter-phase-iii-clinical-trial-to-evaluate-the-safety-tolerability-efficacy-and-pharmacokineticpharmacodynamic-pkpd-characteristics-of-sr604-injection-in-patients-with-hemophilia-ab-and-congenital-factor-vii-deficiency-100641949","NCT07644832","An Open-label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Characteristics of SR604 Injection in Patients With Hemophilia A\u002FB and Congenital Factor VII Deficiency","Inclusion Criteria:\n\n1. Age ≥18 years and ≤65 years at the time of signing informed consent, regardless of sex;\n2. Clinically diagnosed with Hemophilia A or B or congenital coagulation Factor VII deficiency, and must meet the following criteria:\n\n   1. Hemophilia A or B patients with historical or screening FVIII activity level \\\u003C1% or FIX activity level ≤2%; Note: Hemophilia A or B patients with or without inhibitors may be enrolled. For patients without inhibitors (inhibitor titer \\\u003C0.6 BU\u002FmL), they must have previously received coagulation factor treatment with exposure days (EDs) \\>50 days.\n   2. Congenital coagulation Factor VII deficiency patients with historical or screening FVII activity \\\u003C10%;\n3. Part A only: Received on-demand treatment with FVIII, FIX, recombinant human coagulation Factor VIIa (rFVIIa), or PCC for bleeding events within 1 month prior to screening;\n4. Part B\u002FPart C only: Accessible bleeding and treatment records (factor replacement or bypassing agent therapy) for at least 3 months prior to enrollment. Hemophilia A or B patients must have received on-demand treatment with ≥3 treated de novo bleeding episodes within 3 months prior to enrollment. Congenital coagulation Factor VII deficiency patients must have ≥2 treated de novo bleeding episodes within 3 months prior to enrollment;\n5. No active bleeding symptoms prior to first dosing;\n6. The subject or a legally acceptable representative has a full understanding of and can comply with the protocol requirements, has the willingness to complete the study as planned, and voluntarily agrees to provide biological samples for testing as required by the protocol;\n7. The subject is able to understand the procedures and methods of this clinical trial, has been fully informed, and voluntarily participates in the trial by personally signing the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with a known history of hypersensitivity to the investigational medicinal product or any of its components;\n2. Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect administration and safety assessment;\n3. Subjects meeting any of the following criteria at screening:\n\n   1. Hemoglobin \\\u003C60 g\u002FL;\n   2. Platelet count \\\u003C100 × 10\\^9\u002FL;\n   3. Hepatic or renal impairment: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN; or serum creatinine (Cr) ≥1.5 × ULN;\n4. Positive result(s) for hepatitis B virus surface antigen (HBsAg), anti-human immunodeficiency virus (HIV) antibody, and\u002For Treponema pallidum-specific antibody;\n5. Clinically diagnosed with active hepatitis C;\n6. Any other bleeding disorder or any other disease causing significant coagulation abnormalities (e.g., platelet disorders, vitamin K deficiency, etc.) other than Hemophilia A or B and congenital coagulation Factor VII deficiency;\n7. Protein C deficiency or protein S deficiency;\n8. History of or current thrombosis, family history of thrombosis, or history of thrombophilia prior to signing informed consent;\n9. Intracranial hemorrhage due to Hemophilia A or B or congenital coagulation Factor VII deficiency within 2 years prior to screening;\n10. Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association Class ≥III), severe arrhythmia (QTc interval \\>450 ms, corrected by Fridericia's formula), or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg);\n11. Received recombinant human coagulation Factor VIIa (rFVIIa) within 48 hours prior to first dosing; received any FVIII-containing product within 72 hours prior to first dosing; received any FIX-containing product within 96 hours prior to first dosing; long-acting products of the above have not completed a washout of 5 half-lives;\n12. Used or requires use of any anticoagulant, antifibrinolytic agent, or chemical drug, biological product, or traditional Chinese medicine affecting platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, within 1 week prior to first dosing or during the trial;\n13. Received whole blood or plasma therapy within 2 weeks prior to first dosing;\n14. Received emicizumab treatment within 6 months prior to first dosing;\n15. Received or planned to receive vaccination within 4 weeks prior to first dosing or during the trial;\n16. Underwent major surgery (e.g., orthopedic surgery, abdominal surgery) within 1 month prior to first dosing, or planned to undergo surgery during the study;\n17. Enrolled in another clinical trial within 1 month prior to first dosing;\n18. History of drug abuse or alcoholism (alcoholism criteria: long-term drinking history exceeding 5 years, equivalent to ethanol intake ≥40 g\u002Fday, or heavy drinking within 2 weeks, equivalent to ethanol intake \\>80 g\u002Fday. Ethanol amount (g) conversion formula = alcohol volume (mL) × ethanol content (%) × 0.8);\n19. Psychiatric illness or significant mental impairment, or incapacity or lack of cognitive ability due to other reasons;\n20. Plans to have children or donate sperm during the entire trial period up to 6 months after the last dose, or unwilling to use effective physical contraceptive measures (e.g., condoms);\n21. Subjects with clinically significant disease or other conditions that the investigator considers unsuitable for participation in the clinical trial (e.g., the patient cannot benefit from the clinical trial);\n22. Subjects deemed by the investigator to have poor compliance, rendering efficacy evaluation impossible or with low likelihood of completing the planned treatment course and follow-up.","65 Years",{"count":59,"type":22},76,[25,61],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, immunogenicity , PK, and PD of a single dose of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors （Part A）and to evaluate the safety, PK, PD, and efficacy of multiple doses of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B and Part C).",[29,30,31],"2026-06-08",{"date":66,"type":42},"2026-06-12",{"date":68,"type":42},"2024-05-31",{"date":70,"type":22},"2026-12-31",{"name":72,"class":49},"Shanghai RAAS Blood Products Co., Ltd.",9]