in Adults with Different Rabies Exposure Risks
Conditions
Interventions
This study will compare SYN023 to the usual licensed anti-
rabies antibody treatment,
rabies immune globulin (HRIG) that is give with vaccination.,About half of the subjects will receive SYN023. The other half will receive the licensed HRIG,
HyperRab® S/D.
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
Low risk group,Low risk group
Sponsors
Synermore Biologics Co., Ltd.
Synermore Biologics Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Be at least 18 age years on Study Day 1 Agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study Live within 30 km of study center For female subjects: agrees to avoid pregnancy from Study Day 1 through Study Day 121. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide Has body mass index (BMI) between 18 and 36 (weight/height2) by nomogram
Exclusion criteria
Exclusion criteria: 1.Clinical evidence of rabies infection 2.Rabies exposure > 54 hours before SYN023 or HRIG receipt 3.History or serological evidence of previous rabies vaccination 4.Previous receipt of equine or human rabies globulin 5. History of hypersensitivity reaction to equine or human immunoglobulin. Received immunoglobulin or blood products within 42 days before Study Day 1 6. Received any investigational drug therapy or investigational vaccine within 180 days before Study Day 1 7. Planned participation in any other investigational study during the study period. 8. Received systemic immunosuppressant medication not specified by the protocol 9. History or laboratory evidence of any past, present, or possible immunodeficiency state including but not limited to any laboratory indication of HIV infection 10. Previous medical history that may compromise the safety of the subject in the study according to the opinion of the principal investigator 11. History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or activity of SYN023 12. Pregnancy. Female subjects: agree to avoid pregnancy from Study Day 1 through Study Day 121. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics of administered SYN023/HRIG. Study Day 1 through Study Day 15 The first composite element is superiority of the geometric mean SYN023 AUEC1-15.,The immune response to rabies vaccine Study Day 99 RVNA in SYN023 recipients compared to Study Day 99 geometric mean concentration of RVNA in the HRIG.,The occurrence of Rabies. 365 days No cases of rabies in the per protocol population of either treatment arm | — |
Secondary
| Measure | Time frame |
|---|---|
| SYN023 recipients with blood RVNA concentration meet general accept as adequate threshold >0.5IU/mL. 365 days Geometric mean concentrations of RVNA at each time point (SYN023 gr.) divided by geometric mean conc,Pharmacokinetic Analysis 365 days using non compartmental analysis, Vd,Cmax,Tmax, AUC0-t, AUC0-inf, t½, Cl, and λz,Immunogenicity Anti-SYN023 Antibodies 365 days The presence and effect of anti-SYN023 antibodies (anti-CTB011, anti-CTB012) will be evaluated. | — |
Countries
Thailand
Contacts
Public ContactPope Kosalaraksa
Srinagarind Hospital
Outcome results
None listed