None listed
Conditions
Interventions
Intervention1: ZRC-3306(Test IP): Dose : three dose levels (1 mcg, 5 mcg, and 10 mcg)If no any safety concerns are identified in initial three cohorts, further dose cohort of 25 mcg and 50 mcg will be
Sponsors
Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant, non-lactating female subjects aged 18 to 65 years at screening (Both inclusive). 2. Body mass index between 18.5 to 29.9 kg/m2 (Both inclusive) at screening. 3. Ability to communicate effectively with study personnel. 4. Be able to give consent for participation in the trial. 5. Normal health as determined by personal medical/surgical history, physical examination, ECG and laboratory assessment data during screening (within the clinically acceptable range). 6. Serum LDL level of =129 mg/dL at screening. 7. Serum triglyceride levels of = 400 mg/dL at screening 8. Female subjects with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) and be willing and able to continue contraception till study completion after administration of study treatment. 9. Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception till study completion after administration of study treatment. 10. Must be willing and able to communicate and participate in the whole study. 11. Subject should be literate to understand study requirement.
Exclusion criteria
Exclusion criteria: 1. History of alcohol consumption or tobacco use or drug abuse within past 1 year of enrollment or subject currently taking alcohol and/or tobacco products. 2. Presence or history of any of the disorder/disease within the past 3 months that might have impact on the clinical trial as per the investigator’s discretion i.e., cardiovascular, nervous system, gastrointestinal, respiratory or any other major disorder 3. History or presence of diagnosed or treated for allergic reaction to diphtheria toxin. 4. Difficulty with donating blood. 5. Systolic blood pressure more than 140 mmHg or lesser than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg. 6. Pulse rate less than 60/minute or more than 100/min. 7. Any clinically significant laboratory or ECG finding during screening as per discretion of investigator. 8. Any vaccine administration within 90 days from drug administration and who are planning to take vaccine during study period 9. Surgery within last 3 months or planned major surgery during the study period 10. Any major illness during last 3 months as per investigator’s discretion 11. Subject who have participated in drug research study within past 3 months. 12. Subject who have donated one unit (350 ml) of blood in past 3 months. 13. Use of any over the counter, any prescription medications or alternative tradition of medicine (Herbal medicines, homeopathy, siddha, Unani, etc.) within the 14 days prior to receiving study drug that might have impact on the clinical trial as per investigator’s discretion. 14. History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reaction. 15. Subject who are found positive urine alcohol test and urine test of drug of abuse 16. For female subjects, positive serum ß-hCG level or urine pregnancy test at the screening or check-in visit. 17. Female subjects with history of pregnancy or lactation in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence, severity & relationship of treatment emergent adverse events (of anti-PCSK9 product) investigational product during the studyTimepoint: Baseline & Day 388 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess Percentage of PCSK9-LDL-R interaction inhibition.Timepoint: Baseline & Day 388;To assess the LDL lowering activity of anti-PCSK9 productTimepoint: Baseline & Day 388;To assess the level of antibodies against anti-PCSK9 product.Timepoint: Baseline & Day 388 | — |
Countries
India
Contacts
Public ContactDr Gaurav Jansari
Zydus Lifesciences Ltd
Outcome results
None listed