CTRI/2024/01/062126
Recruiting
Phase 1
A Phase 1, Prospective, Randomized, Double blind, Parallel, Placebo-controlled, Single period, Multiple dose study to evaluate safety and tolerability of Anti-PCSK9 Product (ZRC-3306) administered subcutaneously in healthy adult human subjects - NI
Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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