Clinical Study of AK159 in Healthy Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 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 Part 1 and Part 2. <Part 1> Part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide acetate for injection as a control.
<Part 2> Part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. Pharmacokinetics, safety, and tolerability following long-term application will also be investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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; and 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
- •Systolic blood pressure < 90 mmHg
- •QTc exceeds 470 msec in a 12-lead electrocardiography
- •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 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 MN-10-T
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 3
Multiple administration of AK159 dose level 3
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
Peak Plasma Concentration (Cmax) of teriparatide
时间窗: up to 6 hours after single and repeated administration
Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).
时间窗: up to 24 hours after single and repeated administration
次要结局
- Change from Baseline in bone turnover markers within 24 hrs at each administration
- Residual teriparatide in the patch after application