Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
研究概览
简要总结
This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.
Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.
Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BMI greater than 27.0 and less than 35.0 kg/m2
排除标准
- •Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
- •Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
- •Eating disorders
- •Unusual diets or eating habits
- •Dieting, use of diet drugs or obesity surgery
- •Diabetes history or abnormal fasting glucose
研究组 & 干预措施
C
干预措施: NNC 0070-0002-0349 (Drug)
A
干预措施: NNC 0070-0002-0349 (Drug)
A
干预措施: placebo (Drug)
B
干预措施: NNC 0070-0002-0349 (Drug)
B
干预措施: placebo (Drug)
C
干预措施: placebo (Drug)
D
干预措施: NNC 0070-0002-0349 (Drug)
D
干预措施: placebo (Drug)
E
干预措施: NNC 0070-0002-0349 (Drug)
E
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
时间窗: Including screening and evaluation: after approx. 7 weeks
次要结局
- Time to maximum plasma concentration(21 days following dosing)
- Maximum plasma concentration(21 days following dosing)
- AUC (area under the curve)(21 days following dosing)
- Half life(21 days following dosing)