ISRCTN16878305已完成1 期
A Phase I, open-label, single-dose pharmacokinetic study of IPP-201101 after subcutaneous and intravenous administration in healthy male volunteers
ImmuPharma S.A0 个研究点目标入组 16 人开始时间: 2023年9月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Healthy male volunteer, between 18 and 55 years of age, inclusive
- •2. Male volunteer (and partner of childbearing potential) willing to use a highly effective method of contraception or two effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the volunteer) from first dose until 3 months after last dose of IMP.
- •3. Volunteer with a body mass index (BMI) of 18-32 kg/m². BMI = body weight (kg) / [height (m)]²
- •4. No clinically significant history of previous allergy/sensitivity to IPP 201101 or any of the excipients contained within the IMP
- •5. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP
- •6. Volunteer with a negative urinary drugs of abuse (DOA) toxicology screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP (N.B. A positive test result may be repeated at the Investigator’s discretion)
- •7. Volunteer with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening
- •8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before the first dose of IMP including a PR interval > 220ms or QT interval corrected using Fredericia’s formula (QTcF) >450 ms
- •9. No clinically significant abnormalities in vital signs (blood pressure/heart rate, oral temperature) determined within 28 days before the first dose of IMP
- •10. Volunteer must be available to complete the study (including all follow-up visits)
- •11. Volunteer must satisfy an Investigator about his/her fitness to participate in the study
- •12. Volunteer must provide written informed consent to participate in the study
- •13. Participants with a negative coronavirus disease 2019 (COVID-19) test on admission (if required)
排除标准
- •1. Evidence of clinically significant renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
- •2. Individual or family history of pre-existing autoimmune or antibody-mediated diseases
- •3. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP
- •4. Volunteers who have received any prophylactic vaccine (including COVID-19 vaccine) or immunisation within the last 28 days or use of corticosteroids or immunosuppressive drugs within 28 days of IMP administration
- •5. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units of alcohol a week for male volunteers) within the past 2 years
- •6. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function)
- •7. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives whichever is the longest, or a marketed drug clinical study within the 30 days or five half-lives whichever is the longest, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- •8. Donation of 450 millilitres (ml) or more blood within the 3 months before the first dose of IMP
- •9. Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc)
- •10. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within 3 months prior to first dose administration with the study medication or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums)
- •11. Volunteers who do not have suitable veins for multiple venepunctures/cannulation
- •12. Volunteers who have any clinical condition or prior therapy which, in the opinion of the Investigator, could jeopardize the safety or rights of a volunteer participating in the trial or would render them unable to comply with the protocol
- •13. Volunteers who are study site employees, or immediate family members of a study site or sponsor employee
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