A Phase I Study of AK159 in Healthy Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of teriparatide
研究概览
简要总结
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
详细描述
This study consists of two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women.
The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy postmenopausal ethnic Japanese women
- •At least 45 years of age at the time consent is obtained
- •Give voluntary consent in writing with a sufficient understanding of the study.
排除标准
- •Clinical abnormality identified in the laboratory tests
- •Weight < 40.0 kg
- •Body mass index < 17.5 or >=30.5
- •History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects
- •Previously received radiation treatment potentially affecting bone
- •Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period
- •Systolic blood pressure < 90 mmHg
- •Serum calcium level exceeding 10.4 mg/dL
- •History of contact dermatitis or skin disease potentially compromising study evaluation
- •Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration
- •Used a bisphosphonate
- •Used a teriparatide product
研究组 & 干预措施
AK159 MD 3
Multiple administration of AK159 dose level 3
干预措施: AK159 (Drug)
AK159 SD 1
Single administration of AK159 dose level 1
干预措施: AK159 (Drug)
AK159 SD 2
Single administration of AK159 dose level 2
干预措施: AK159 (Drug)
AK159 SD 3
Single administration of AK159 dose level 3
干预措施: AK159 (Drug)
AK159 SD 4
Single administration of AK159 dose level 4
干预措施: AK159 (Drug)
MN-10-T SD
Single administration of teriparatide acetate
干预措施: MN-10-T (Drug)
AK159 MD 1
Multiple administration of AK159 dose level 1
干预措施: AK159 (Drug)
AK159 MD 2
Multiple administration of AK159 dose level 2
干预措施: AK159 (Drug)
AK159 MD 4
Multiple administration of AK159 dose level 4
干预措施: AK159 (Drug)
MN-10-T MD
Multiple administration of MN-10-T
干预措施: MN-10-T (Drug)
Placebo MD
Multiple administration of placebo AK159
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of teriparatide
时间窗: up to 6 hours after single and repeated administration
Number of subjects with adverse events and Incidence of adverse events
时间窗: up to 7 weeks after the initial administration
Peak Plasma Concentration (Cmax) of teriparatide
时间窗: up to 6 hours after single and repeated administration
Change in bone turnover markers from baseline
时间窗: up to 7 weeks after the initial administration
次要结局
- Visual assessment of the application site(up to 7 weeks after the initial administration)