A Bridging Study of the SYN023 on Healthy Adult Subjects (NCT04495569) | Clinical Trial Compass
CompletedPhase 1/2
A Bridging Study of the SYN023 on Healthy Adult Subjects
China33 participantsStarted 2019-02-26
Plain-language summary
The Phase I bridging clinical trial is to evaluate on the safety, pharmacokinetics (PK), pharmacodynamics (PD) and ADA of a single intramuscular injection of recombinant anti-rabies human monoclonal antibody injection (SYN023) alone or combined with rabies vaccine in healthy subjects. The study primary purpose was to compare the pharmacokinetics (PK) between U.S and China subjects, therefore to lay a foundation for the follow-up clinical trials. The secondary purpose was to evaluate the PK, PD, Safety and ADA of SYN023 in Chinese Healthy subjects and compare with that of U.S. subjects.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Sign the informed consent before the trial, fully understand the trial contents, process and possible adverse reactions, and cooperate to observe the adverse events;
✓. Could participate the entire study according to the protocol;
✓. Subjects including partners are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last study drug administration.
✓. Male and female healthy subjects aged 18-50 (including 18 and 50 years old)
✓. The weight of male subjects shall not be less than 50 kg, and that of female subjects shall not be less than 45 kg and shall not be more than 90 kg. Body mass index (BMI) = body weight (kg) / height\^2 (m\^2), body mass index should be in the range of 18-30 kg/m2 (including);
✓. Physical examination and vital signs are in normal range or the abnormality without clinical significance, and the body temperature is ≤ 37.6 °C.
Exclusion criteria
✕. Smoked over 5 cigarettes per day for 3 months before the trial;
✕
What they're measuring
1
To compare the Tmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine
Timeframe: 85 days
2
To compare the Cmax between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
Timeframe: 85 days
3
To compare the t1/2 between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
Timeframe: 85 days
4
To compare the Clearance rate between Chinese and American subjects with a single dose of 0.3 mg/kg SYN023 alone or combined with rabies vaccine.
Timeframe: 85 days
5
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012
. History of allergy (multi drugs and food allergy); history of severe allergic disease or allergic reaction; including allergy to any component of this drug;
✕. History of alcohol addiction (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine);
✕. Blood donation or massive blood loss (\> 450 mL) occurred within 3 months before screening;
✕. History of autoimmune diseases;
✕. History of chronic hepatitis ;
✕. History of rabies virus infection;
✕. Other acute or chronic diseases (within 6 months) that may interfere with the safety and efficacy evaluation of the subjects according to the investigator's judgment;