Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

1. Male and female healthy volunteers in age group 18-45 years (both inclusive), <br/ > 2. The subjects voluntarily agreed to participate in the study, and signed an informed consent form, willing to comply with protocol requirements. <br/ > 3. Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening. <br/ > 4. Body temperature is between 95.6 to 99.0 ºF. <br/ > 5. Body mass index (BMI) at 18.5 to 30.0 kg/m2 (inclusive). <br/ > 6. Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication. <br/ > Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. <br/ > Note-Female patients of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study drug. For this study, acceptable and effective methods of contraception for females include: <br/ > -Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, <br/ > -Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or <br/ > -Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). <br/ > For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.

1. Male and female healthy volunteers in age group 18-45 years (both inclusive), <br/ > 2. The subjects voluntarily agreed to participate in the study, and signed an informed consent form, willing to comply with protocol requirements. <br/ > 3. Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening. <br/ > 4. Body temperature is between 95.6 to 99.0 ºF. <br/ > 5. Body mass index (BMI) at 18.5 to 30.0 kg/m2 (inclusive). <br/ > 6. Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication. <br/ > Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. <br/ > Note-Female patients of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study drug. For this study, acceptable and effective methods of contraception for females include: <br/ > -Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, <br/ > -Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or <br/ > -Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). <br/ > For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.