| CTRI Number |
CTRI/2024/01/062126 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Phase 1 study to evaluate safety and tolerability of Anti-PCSK9 Product (ZRC-3306) administered subcutaneously in healthy adult human subjects |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZYPCSK9 1001,Ver 01,29 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Jansari |
| Designation |
Senior Scientist |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre,
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382210, Gujarat,
Ahmadabad
GUJARAT
382210
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Gaurav.Jansari@zyduslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Jansari |
| Designation |
Senior Scientist |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre,
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382210, Gujarat,
Ahmadabad
GUJARAT
382210
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Gaurav.Jansari@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Jansari |
| Designation |
Senior Scientist |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Centre,
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382210, Gujarat,
Ahmadabad
GUJARAT
382210
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Gaurav.Jansari@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Ltd,
Zydus Research Centre, Survey No. 396/403,
Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad 382210, Gujarat, India, |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited |
| Address |
Zydus Research Centre,
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382210, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Jansari |
Zydus Research Centre |
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals,
Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad-382210, Gujarat, India
Ahmadabad
GUJARAT |
02717-665555
Gaurav.Jansari@zyduslife.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Home Ethics Committee,Jalaram Plaza,Maninagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Matching Placebo 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 enrolled. Prior to enrollment of these two cohorts ethics committee approval will be taken for dose escalation of 25 and 50 mcg.
Route :- Subcutaneous
Duration :- Day 0 (first dose), Day 28 (second dose), Day 208 (third dose, i.e., 6 months after second dose) |
| Intervention |
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 enrolled. Prior to enrollment of these two cohorts ethics committee approval will be taken for dose escalation of 25 and 50 mcg.
Route :- Subcutaneous
Duration :- Day 0 (first dose), Day 28 (second dose), Day 208 (third dose, i.e., 6 months after second dose) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 β-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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence, severity & relationship of treatment emergent adverse events (of anti-PCSK9 product) investigational product during the study |
Baseline & Day 388 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the LDL lowering activity of anti-PCSK9 product |
Baseline & Day 388 |
| To assess the level of antibodies against anti-PCSK9 product. |
Baseline & Day 388 |
| To assess Percentage of PCSK9-LDL-R interaction inhibition. |
Baseline & Day 388 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Increased
levels of lipids (hyperlipidemia), particularly low-density lipoprotein
cholesterol (LDLc) is considered the major risk factor for developing
atherosclerotic plaques, causing a variety of cardiovascular events. Anti-PCSK9
Product (ZRC-3306) is a PCSK9 inhibitor which regulates the levels of LDL
receptors that are responsible for the uptake and clearance of cholesterol from
the blood. This Phase I prospective randomised, double-blind, placebo-controlled
study will evaluate the safety and tolerability of anti-PCSK9 product
administered subcutaneously in healthy human volunteers.Increased
levels of lipids (hyperlipidemia), particularly low-density lipoprotein
cholesterol (LDLc) is considered the major risk factor for developing
atherosclerotic plaques, causing a variety of cardiovascular events. Anti-PCSK9
Product (ZRC-3306) is a PCSK9 inhibitor which regulates the levels of LDL
receptors that are responsible for the uptake and clearance of cholesterol from
the blood. This Phase I prospective randomised, double-blind, placebo-controlled
study will evaluate the safety and tolerability of anti-PCSK9 product
administered subcutaneously in healthy human volunteers.
|