A phase 1 study of ZYAT1 administered via oral route to determine the safety, tolerability and pharmacokinetics in healthy adult human participants.
- Registration Number
- CTRI/2024/06/069497
- Lead Sponsor
- Zydus Lifesciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy male or non-lactating non-pregnant female between 18 and 55 years (Both inclusive) of age at the time of signing the informed consent form (ICF).
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 QTcF =450 ms
4.Male participants must agree to use adequate contraception methods during the study and be willing and able to continue contraception till study completion.
5.Capable of willingly giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
6.Participants 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 participants 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.
1.History or presence of alcoholism or drug abuse within the past 1 year and consumption of alcohol and/or tobacco products in last 48 hr.
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.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug.
4.Difficulty with donating blood or Inability to be venipunctured or tolerate venous puncture.
5.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.
6.Pulse rate less than 60/minute or more than 100/minute.
7.Any clinically significant laboratory or ECG findings during screening
8.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).
9.Participants who have recent illness (eg, fever) within 14 days of enrollment.
10.Volunteers who have participated in any drug research study within past 3 months.
11.Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
12.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 15 days of enrollment, 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 enrollment.
13.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.
14.A positive urine drugs of abuse test or positive alcohol test at check-in.
15.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.
16.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.
17.Any condition or abnormal baseline findings that in the Investigator’s judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
18.Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for the study.
19.Female participants who are pregnant, currently breastfeeding, or attempting to conceive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method