ISRCTN85112396进行中（未招募）1 期
A first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of GUB014295 in lean to overweight or obese but otherwise healthy men
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Gubra A/S
- 入组人数
- 48
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. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •3. Males aged 18 to 55 years inclusive at the time of signing informed consent
- •4. Must agree to adhere to the contraception requirements defined in the clinical protocol
- •5. Lean to overweight or obese but otherwise healthy males
- •6. BMI of 22.0 to 32.0 kg/m² as measured at screening. Overweight or obese as assessed by BMI should be due to excess adipose tissue, as judged by the investigator
- •7. Weight =70 kg at screening
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. Known or suspected hypersensitivity or allergy to paracetamol
- •4. Presence or history of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, haematological or venereal disorder, as judged by the investigator
- •5. Presence or history of any clinically relevant gastrointestinal diseases or symptoms of gastrointestinal disorders potentially affecting interpretation of study data, e.g. by affecting absorption of nutrients or drugs, as judged by the investigator
- •6. Presence or history of diseases associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
- •7. History of major depressive disorder within 2 years prior to screening or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) or suicidal attempt
- •8. Subjects unable to take NSAIDs for any reason
- •9. Subjects unable to take paracetamol for any reason
- •10. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •11. Subjects with tattoos or scars on the abdomen which may interfere with injection site assessments as determined by the investigator or delegate at screening
- •12. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
- •13. HbA1c =48 mmol/mol (=6.5%) and/or fasting plasma glucose =7.0 mmol/L at screening
- •14. Prolongation of the QTcF over 450 msec or any other clinically significant abnormal ECG results as judged by the investigator
- •15. Supine blood pressure (after =5 min rest) <90 mmHg or >150 mmHg (systolic) and/or <50 mmHg or >90 mmHg (diastolic)
- •16. Heart rate (ECG-recorded after =5 min rest) <45 or >90 beats per minute
- •17. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •18. Evidence of renal impairment at screening, as indicated by an estimated GFR of <80 mL/min/1.73m² using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation
- •19. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •20. Subjects who have previously been administered IMP in this study
- •21. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •22. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies/vitamins in the 14 days
- •before IMP administration. Paracetamol will be permitted until 48 h prior to Day -1 except 48 h prior to the mixed meal tests on Day -1 and Day 4 (Cohorts 2 to 6) where paracetamol is not permitted. NSAIDs can be given at the discretion of the investigator to treat any AEs if necessary (up to 4 g per day). Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does
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