ISRCTN69500549进行中（未招募）1 期
A randomised, placebo-controlled first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GCG-06 in healthy normal weight/overweight subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- All
入选标准
- •1. Male and females of non-childbearing potential non-smokers aged 18-70 years old
- •2. Body mass index 20-30 kg/m2
- •3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
- •4. Able to communicate with study personnel
- •5. Reliable, willing, and likely to comply with the protocol
- •6. Willing to comply with the contraception and gamete donation requirements of the protocol and consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS).
排除标准
- •1. Unhealthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine)
- •2. Diabetes or prediabetes
- •3. Abuse or have abused alcohol or drugs in the last 2 years
- •4. Drink, on average, more than 14 units of alcohol weekly
- •5. Have been treated by a doctor for severe allergic disease (such as severe asthma, severe hay fever requiring regular treatment, or severe eczema)
- •6. Currently taking certain medicines to treat diabetes
- •7. Taken prescription medicine during the 14 days before dosing; taken other medicine (except paracetamol or routine vitamins), herbal remedies or dietary supplements during the 7 days before the first dose; have had a serious reaction to any medicine
- •8. Have suffered from migraines in the last 3 years
- •9. Have a clinically relevant surgical history
- •10. Have had a serious reaction to any medicine
- •11. History of pancreatitis or pancreatic cancer
- •12. A history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- •13. Have acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heartburn) at screening or admission
- •14. Have a current infection (such as flu)
- •15. Have had any condition or operation that might affect the way the body absorbs medicines
- •15. Have had any clinically significant disease
- •16. Taken GCG-06 in the past
- •17. Have a history or evidence of abnormal eating behaviour
- •18. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study
- •19. Have donated plasma in the 7 days before screening, blood in the 3 months before screening, or platelets in the 6 weeks before screening; have taken part in another clinical trial within 3 months before the first admission or are in the follow-up period of a clinical trial (where the last dose was taken more than 3 months before); or don't agree to donate blood, or take part in another study, during the 3 months after this study — because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood;
- •20. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of GCG-06; mental illness might compromise consent
研究者
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