CTRI/2021/07/034692 [Registered on: 08/07/2021] Trial Registered Prospectively
Last Modified On:
26/03/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Study Of Phase I multiple dose escalation trial of ZYIL1 Via Oral Route To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Healthy Adult Human Subjects
Scientific Title of Study
A phase I, prospective, open label, multiple dose study of ZYIL1 administered via oral route to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult subjects
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ZYIL1 1002 Version 01, 17 May 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Taufik Momin
Designation
Deputy General Manager
Affiliation
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,
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
Taufik.Momin@zyduscadila.com
Details of Contact Person Scientific Query
Name
Dr Kevinkumar Kansagra
Designation
General Manager
Affiliation
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,
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
Kevinkumar.Kansagra@zyduscadila.com
Details of Contact Person Public Query
Name
Dr Kevinkumar Kansagra
Designation
General Manager
Affiliation
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,
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
Kevinkumar.Kansagra@zyduscadila.com
Source of Monetary or Material Support
Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad 382213, Gujarat, India
Primary Sponsor
Name
Cadila Healthcare Ltd
Address
Zydus Corporate Park, 3rd Floor B Wing (NPD), Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad – 382 481
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Taufik Momin
Zydus Research Centre
Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. N. 8A, Moraiya, Ahmedabad-382213 Ahmadabad GUJARAT
Ahmadabad
GUJARAT Ahmadabad GUJARAT
02717665555
Taufik.Momin@zyduscadila.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sangini Hospital Ethics Committee C/o Sangini Hospital, First Floor, Santorini Square, b/h Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NIL
NIL
Intervention
ZYIL1 Capsule
1)Route of Administration:Oral
2.Frequency: Multiple dose
3)Dose :- as per Cohort.
4) Duration : 16 days post dose monitoring for each subjects.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
1. Healthy male or non-lactating non-pregnant female between 18 and 55 years of age at the time of signing the informed consent form (ICF). (Both inclusive).
2. Body mass index of 18.5 to 30.0 kg/m2 (Both inclusive) with a body weight of 50 to 100 kg (Both inclusive).
3. Normal QTc interval at screening and Check In [QTcF ≤450 ms]
4. Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception for 90 days after administration of study treatment.
5. Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
6. Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: hematology, serum biochemistry, urinalysis, and serology.
7. 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 for 90 days after administration of study treatment.
ExclusionCriteria
Details
1. History or presence of alcoholism or drug abuse within the past 1 year.
2. Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion: cardiovascular, cerebrovascular, dermatological, gastrointestinal, gynecological, hematological, hepatic, malignancy, metabolic, musculoskeletal, neurological, urological, psychiatric, renal, respiratory, venereal, any other major disorders
3. History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the Investigator.
4. History of COVID-19 infection within 14 days or contact with a confirmed active COVID-19 positive patient within 14 days; or positive COVID-19 test within 5 days of Check-in. .
5. History or presence of smoking or consumption of tobacco/nicotine products within the past 1 year.
6. Difficulty with donating blood.
7. Systolic blood pressure more than 140 mmHg or less than 100 mmHg or diastolic blood pressure more than 90 mmHg or less than 60 mmHg.
8. Pulse rate less than 55/minute or more than 100/minute.
9. Any clinically significant laboratory or ECG findings during screening
10. Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).
11. Subjects who have recent illness (eg, fever) within 14 days of check-in
12. Volunteers who have participated in any drug research study within past 3 months.
13. Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
14. Has used prescription drugs and other substances (eg, dietary or herbal supplements such as St John’s Wort) known to be either significant enzyme inducers or enzyme inhibitors within 4 weeks of Day 1, or use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days of Day 1.
15. Use of any over-the-counter (OTC), any prescription medications or alternative tradition of medicine (herbal medicines, homoeopathy, Siddha, Unani, etc.) within the 15 days or 5 half-lives (whichever is longer), prior to receiving study drug that might have impact on the clinical trial as per the investigator discretion.
16. A positive urine drugs of abuse test or positive alcohol test at check-in.
17. History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II.
18. Any disorder that, in the Investigator’s opinion, may interfere with study compliance, such as significant mental, nervous disorder or other illness. In making this assessment, the Investigator must refer to the study information provided including the Investigator’s Brochure.
19. Inability to be venipuncture or tolerate venous puncture.
20. Any condition or abnormal baseline findings that in the Investigator’s judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
21. Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the subject unsuitable for the study.
22. Female subjects who are pregnant, currently breastfeeding, or attempting to conceive.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate safety and tolerability of ZYIL1 administered to healthy subjects.
Screening and Day 16
Secondary Outcome
Outcome
TimePoints
• To characterize the pharmacokinetics of ZYIL1 when administered as a multiple oral dose to healthy subjects.
Day 1, Day 2, Day 3, Day 5, Day 7, Day 10, Day 13, Day 14, Day 15 and Day 16
Target Sample Size
Total Sample Size="18" Sample Size from India="18" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="18"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting cytokine storm related to COVID-19 and other inflammatory diseases.
This Study aims to determine the pharmacokinetics , pharmacodynamics, safety and tolerability of ZYIL1 when administered in multiple doses of 14 days.