HealthyPhase 1NCT04972188
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers
A Phase 1 study testing ZYIL1 Capsule in people with Healthy, run by Zydus Lifesciences Limited at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ZYIL1 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jul 2021to 25 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Body mass index of 18.5 to 30.0 kg/m2 (Both inclusive) with a body weight of 50 to 100 kg (Both inclusive).
- Normal QTc interval at screening and Check In [QTcF ≤450 ms]
- 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.
- Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
- 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.
- 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.
Who cannot join
- History or presence of alcoholism or drug abuse within the past 1 year.
- 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
- History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the Investigator.
- 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. .
- History or presence of smoking or consumption of tobacco/nicotine products within the past 1 year.
- Difficulty with donating blood.
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- 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.
- Pulse rate less than 55/minute or more than 100/minute.
- Any clinically significant laboratory or ECG findings during screening
- 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).
- Subjects who have recent illness (eg, fever) within 14 days of check-in
- Volunteers who have participated in any drug research study within past 3 months.
- Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
- 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.
- 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.
- A positive urine drugs of abuse test or positive alcohol test at check-in.
- 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.
- 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.
- Inability to be venipuncture or tolerate venous puncture.
- 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.
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the subject unsuitable for the study.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
It is an open label, study designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following a multiple-oral dose administration of ZYIL1 to healthy subjects aged between 18-55 years old (Both Inclusive).
It will be conducted in up to 3 cohorts of 6 subjects each. Each cohort will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be administered multiple oral dose of ZYIL1 from day 1 to till day 14.
- Conditions
- Healthy
- Being tested
- ZYIL1 Capsule
- Keywords
- NLRP3, NLPR3 Inflammasone inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYIL1 CapsuleDrug
NLRP3 inflammasome inhibitor
| Study group | Role | What they receive |
|---|---|---|
| ZYIL1 | Experimental | Capsule administration. Six subjects will be recruited in each cohort. safety data up to day 14 will be evaluated. Single dose will be administered in ascending manner starting from 12.5 mg. Receives: Drug: ZYIL1 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse event of ZYIL1 following a Multiple oral dose in healthy subjects
he Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading
Measured: Baseline to Day 19
Secondary outcomes (1)
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
At each dose level, blood samples will be withdrawn for the evaluation of pharmacokinetic.
Measured: Day 1 to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start12 Jul 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Phase I, Prospective, Open Label, Multiple Dose study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study chair, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972188
- Sponsor's protocol ID
- ZYIL1 1002
- Status last verified
- Jun 2021
- First submitted
- 15 Jul 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04972188
- Acronym / sponsor ID
- ZYIL1 1002
- Conditions
- Healthy
- Keywords
- NLRP3, NLPR3 Inflammasone inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is an open label, study designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following a multiple-oral dose administration of ZYIL1 to healthy subjects aged between 18-55 years old (Both Inclusive).
It will be conducted in up to 3 cohorts of 6 subjects each. Each cohort will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be administered multiple oral dose of ZYIL1 from day 1 to till day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Phase I, Prospective, Open Label, Multiple Dose study
| Arm | Type | Receives |
|---|---|---|
| ZYIL1 | Experimental | Drug: ZYIL1 CapsuleCapsule administration. Six subjects will be recruited in each cohort. safety data up to day 14 will be evaluated. Single dose will be administered in ascending manner starting from 12.5 mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
- Body mass index of 18.5 to 30.0 kg/m2 (Both inclusive) with a body weight of 50 to 100 kg (Both inclusive).
- Normal QTc interval at screening and Check In [QTcF ≤450 ms]
- 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.
- Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
Key exclusion criteria (22 listed)
- History or presence of alcoholism or drug abuse within the past 1 year.
- 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
- History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the Investigator.
- 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. .
- History or presence of smoking or consumption of tobacco/nicotine products within the past 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZYIL1 CapsuleNLRP3 inflammasome inhibitor | Drug | ZYIL1 |
Primary outcome
Incidence and Severity of Adverse event of ZYIL1 following a Multiple oral dose in healthy subjects
Time frame: Baseline to Day 19
he Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading
1 secondary outcome
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Time frame: Day 1 to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Deven Parmar, MD study chair
Zydus Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZYIL1 Capsule in people with Healthy, run by Zydus Lifesciences Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse event of ZYIL1 following a Multiple oral dose in healthy subjects (time frame: Baseline to Day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.