| CTRI Number |
CTRI/2020/12/030045 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| 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 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 1, Prospective Open Label, Single Dose, Single Arm Study Of ZYIL1 Administered Via Oral Route To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Healthy Adult Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZYIL1 1001 Version 02,07 Dec 2020 |
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 Balaji More |
| Designation |
Senior 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 |
balaji.more@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
|
|
|
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 |
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
|
|
|
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: Single
3) Dose :- as per Cohort.
4) Duration : 48 hours 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 venipunctured 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety and tolerability of ZYIL1 administered to healthy subjects. |
Screening and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetics of ZYIL1 when administered as a single oral dose to healthy subjects. |
Screening and Day 3 |
| To evaluate pharmacodynamic properties of ZYIL1 in healthy subjects |
Screening and Day 3 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
28/12/2020 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
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 viral inflammatory diseases. |