EUCTR2016-002405-19-DE进行中（未招募）1 期
An open label, randomised, three arm, single dose, multicentre, parallel group study in healthy subjects to compare the pharmacokinetics of subcutaneous mepolizumab when delivered as a liquid drug product in a safety syringe or an auto injector with a reconstituted lyophilised drug product from a vial - A ph 3 PK/PD study of SB240563 as liq drug vs lyophylised SD in HV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 243
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- •1. 18 years of age and over at the time of signing the informed consent.
- •TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- •Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring. A subjectwith a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
- •exclusion criteria, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or ability to interpret study results.
- •3. Body weight = 50 kg and body mass index (BMI) within the range 19.0-30kg/m2 (inclusive)
- •4. Male or Female.
- •5. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:
- •a. Non-reproductive potential defined as:
- •- Pre-menopausal females with one of the following:
- •- Documented tubal ligation
- •- Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- •- Hysterectomy
- •- Documented Bilateral Oophorectomy
- •- Post- menopausal females- refer to Appendix 5 for definition
- •b. Subject is of reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (Appendix 5) from 30 days prior to the first dose of study medication and until 16 weeks after the administration of the single dose of study medication.
- •INFORMED CONSENT
- •6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. The subject must be able to understand and communicate in the native language of the site, e.g. German in German sites.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 243
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL)
- •1. ALT >1.5 xULN
- •2. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •3. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •4. QTcF > 450 msec
- •5. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead ECG.
- •CONCOMITANT MEDICATIONS
- •6. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study medication and until study completion, unless in the opinion of the
- •investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •RELEVANT HABITS
- •7. History of regular alcohol consumption within 6 months of the study defined as:
- •8. An average weekly intake of >14 units for females and >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- •9. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. Limit of >500 ng/mL.
- •10. Involved in any activities likely to result in any significant decrease or increase in body weight during the study period (e.g. ‘crash’ dieting, bodybuilding).
- •CONTRAINDICATIONS
- •11. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- •DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
- •12. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- •13. A positive test for HIV antibody.
- •14. Subjects with known, pre-existing helminthes infestation within 6 months prior to Day 1.
- •15. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
- •16. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •17. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •18. A positive pre-study drug/alcohol screen.
- •19. A vulnerable subject. Defined as individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
- •20. Subjects who work for the Sponsor, CRO, or one of the study centres.
研究者
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