A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Each dose arm is safe
研究概览
简要总结
The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.
详细描述
Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 20 and 55 years of age
- •BMI of 18-35 inclusive
- •Able to understand and sign informed consent form
- •Willing and able to be confined at the clinical research center 8.5 days
- •Women who are post-menopausal, surgically sterilized, or agree to use effective form of birth control
- •Women of child bearing potential with a negative pregnancy test at screening and check-in
- •Medically healthy with normal clinical results and ECG/lab profiles at screening and check-in
- •Exclusion Criteria
- •Donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study
- •Pregnancy or become pregnant
- •Participated in another investigational trial 30 days prior
- •Physical examination/medical history indicates clinical condition or concurrent illness unsuitable for study
- •History/presence of clincally significant disease of any body system
- •History/evidence of congenital hon-hemolytic hyperbilirubinemia
- •History/evidence of gall stone disease, stomach or intestinal surgery
- •History/evidence of colorectal cancer
- •History/evidence of GI disease, e.g., malabsorption, Crohn's Disease, etc.
- •History/evidence of skin rashes or dermatitis
- •Taking prescription or over the counter medication (with the exception of oral contraception) during the 7 days preceding confinement to the clinical unit
排除标准
- 未提供
研究组 & 干预措施
cohort A
20 mg dose 20 mg/ML concentration and placebo
干预措施: teduglutide (Drug)
cohort A
20 mg dose 20 mg/ML concentration and placebo
干预措施: tedguglutide (Drug)
Cohort E
10 mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
Cohort AR
20 mg in 50 mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort AR
20 mg in 50 mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
Cohort C
25 mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort F
30mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort C
25 mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
Cohort D
15 mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort D
15 mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
Cohort E
10 mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort F
30mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
Cohort H
50mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
Cohort H
50mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
cohort I
80mg in 50mg/ml concentration and placebo
干预措施: teduglutide (Drug)
cohort I
80mg in 50mg/ml concentration and placebo
干预措施: tedguglutide (Drug)
结局指标
主要结局
Each dose arm is safe
时间窗: Within 1 week of each cohort completion
次要结局
未报告次要终点