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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
SR604 will be administered as SC injection
SR604 will be administered as SC injection.
SR604 will be administered as SC injection.
Xiangya Hospital of Central South University
Changsha, China
RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China
Hefei, China
RECRUITINGJinan Central Hospital
Jinan, China
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, China
RECRUITINGRuijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
COMPLETEDThe Second Hospital of Shanxi Medical University
Taiyuan, China
RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
COMPLETEDXian Central Hospital
Xi'an, China
RECRUITINGZhengzhou People's Hospital
Zhengzhou, China
RECRUITINGPart A: Incidence of AEs/SAEs/AESI
Assessed through clinical signs and symptoms, vital signs, physical examination, laboratory tests (complete blood count, urinalysis, and blood biochemistry), coagulation function \[PT, TT, INR, FIB, APTT, D-dimer\], FDP, 12-lead electrocardiogram, injection site reactions, hypersensitivity/allergic reactions, thrombotic events, etc.;Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
PartA: Incidence of drug-related AEs/SAEs/AESIs
Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
Part A: Number and incidence of patients with anti-drug antibodies (ADA) and neutralizing antibodies
Safety and Immunogenicity of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
Part B/ Part C:Treated total annualized bleeding rate (ABR)
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part A:Single-dose pharmacokinetic (PK) parameters:Peak Plasma Concentration (Cmax)
PK of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
Part B/ Part C:Treated spontaneous annualized bleeding rate
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Treated total annualized joint bleeding rate
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Treated annualized menorrhagia bleeding rate (applicable only to reproductive-age female patients with congenital FVII deficiency and active menstruation)
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Change from baseline in Hemophilia Joint Health Score (HJHS) (for hemophilia A/B patients)
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Change from baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) score
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Multiple-dose pharmacokinetic parameters-Time to Peak Plasma Concentration (Tmax)
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part B/ Part C:Safety and Immunogenicity
Incidence of AEs/SAEs/AESI, Incidence of drug-related AEs/SAEs/AESIs, Number and incidence of patients with anti-drug antibodies (ADA) and neutralizing antibodies
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
Part A:Single-dose pharmacokinetic (PK) parameters:Time to Peak Plasma Concentration (Tmax)
PK of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
Part A:Single-dose pharmacokinetic (PK) parameters:Area Under the Concentration-Time Curve from Zero to Last Quantifiable Time Point (AUC0-t)
PK of a single ascending SC dose of SR604 inparticipants with Hemophilia A or Hemophilia B will be evaluated.
Time frame: Part A: From Baseline (Day 1) up to Day 85
Part B/ Part C:Multiple-dose pharmacokinetic parameters-Peak Plasma Concentration (Cmax)
Time frame: Part B: From Baseline (Day 1) up to Day 211;Part C: From baseline (Day 1) up to Day 393
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