CTRI/2024/06/069497招募中1 期
A phase 1, prospective, open-label study of ZYAT1 administered via oral route to determine the safety, tolerability and pharmacokinetics in healthy adult human participants and patients with Idiopathic Pulmonary Fibrosis (IPF).
Zydus Lifesciences Ltd4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年7月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- (1)The incidence, severity and relationship to ZYAT1 of treatment emergent adverse events (TEAEs).(2)Safety assessments;Physical Examination,vital signs(blood pressure, pulse rate, body temperature), continuous ECG monitoring (for part I only),12-lead ECG,clinical pathology laboratory measurements (hematology, biochemistry, and urinalysis).(3)Estimation of ZYAT1 PK parameters using non-compartmental methods.
研究概览
简要总结
This study aims to determine the pharmacokinetics, pharmacodynamics, safety and tolerability of ZYAT1 when administered single dose (Part I) or multiple doses (Part II) for 14 days to healthy human participants and patients with Idiopathic Pulmonary Fibrosis (IPF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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 less than equla to 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.
- •Note: For Single ascending dose study NOAEL exposure is achieved at 100 mg and hence this part of the study is considered completed.
- •Multiple dose study (IPF Patients): 1)Diagnosis: IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within 12 months of screening and if available surgical lung biopsy and Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF.
- •(Patients will be permitted to continue antifibrotic therapy (nintedanib and/or pirfenidone) if they had been receiving a stable dose for at least 8 weeks before screening.
- •Forced Vital Capacity (FVC) greater than equal 45 percentage of predicted normal
- •Normal QTc interval at screening QTcF less than equal to 450 ms
- •Male participants must agree to use adequate contraception methods during the study and be willing and able to continue contraception till study completion.
- •Participants who, in the opinion of the Investigator, are fit to enroll in the study 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 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.
排除标准
- •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
- •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.
- •12.Has used prescription drugs and other substances (eg, dietary or herbal supplements such as St Johns 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 Investigators 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 Investigators Brochure.
- •17.Any condition or abnormal baseline findings that in the Investigators 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.
- •Note: For Single ascending dose study NOAEL exposure is achieved at 100 mg and hence this part of the study is considered completed.
- •MAD (Part II) IPF patients 1)Acute IPF exacerbation within 4 months prior to screening and or during the screening period (investigator-determined).
- •In the opinion of the Investigator, other clinically significant pulmonary abnormalities or other abnormalities.
- •Lower respiratory tract infection requiring antibiotics within 4 weeks prior to enrolment.4)Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.5)Female participants who are pregnant, currently breastfeeding, or attempting to conceive.6)History of any systemic autoimmune disease.7)Difficulty with donating blood or Inability to be venipuncture or tolerate venous puncture.8)Volunteers who have participated in any drug research study within past 3 months.9)Volunteers who have donated one unit (350 ml) of blood in the past 3 months.10)A positive urine drugs of abuse test or positive alcohol test at check-in.
结局指标
主要结局
(1)The incidence, severity and relationship to ZYAT1 of treatment emergent adverse events (TEAEs).(2)Safety assessments;Physical Examination,vital signs(blood pressure, pulse rate, body temperature), continuous ECG monitoring (for part I only),12-lead ECG,clinical pathology laboratory measurements (hematology, biochemistry, and urinalysis).(3)Estimation of ZYAT1 PK parameters using non-compartmental methods.
时间窗: Baseline to end to study
次要结局
- To assess the pharmacodynamic effect of ZYAT1 by estimation of plasma Lysophosphatidic acid (LPAs).(Baseline to end of study)
研究者
Dr Krunal Prajapati
Zydus Lifesciences Ltd
研究点 (4)
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