A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
研究概览
简要总结
This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 20 to 70 years
- •Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive
- •Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (Consensus Guidelines 1998 and 2007)
- •Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- •GH replacement therapy for at least 3 months
- •Willing to maintain current activity level during the trial
- •Subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with Good Clinical Practice (GCP)
排除标准
- •History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
- •Active malignant disease or malignant disease within the last 5 years
- •Proliferative retinopathy judged by retina-photo within the last year
- •Heart insufficiency as judged by the investigator and/or NYHA 3 or greater (NYHA criteria for diagnosis of diseases of the heart, 1994)
- •Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment
- •Stable pituitary hormone replacement therapy for less than 3 months
- •Impaired liver function as judged by the investigator or hepatic transaminases > 2 times the upper limit of normal
- •Impaired kidney function as judged by the investigator and/or creatinine clearance <50 mL/min and/or serum creatinine > 1.4 mg/dL
- •Participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or participation in another interventional clinical study involving an investigational compound during this study.
- •Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
- •History or presence of alcohol abuse or drug abuse.
- •Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies
研究组 & 干预措施
ACP-001, 0.02 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks
干预措施: ACP-001 (TransCon hGH) (Drug)
ACP-001, 0.04 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks
干预措施: ACP-001 (TransCon hGH) (Drug)
ACP-001, 0.08 mg hGH/kg/wk
Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks
干预措施: ACP-001 (TransCon hGH) (Drug)
Omnitrope, 0.04 mg hGH/kg/wk
Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks
干预措施: Omnitrope (Drug)
结局指标
主要结局
Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
时间窗: Start of study treatment through Week 4
Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.
Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation
时间窗: Start of study treatment through Day 42
Number of subjects with treatment emergent anti-hGH binding antibodies
次要结局
- Cmax of hGH(Days 22 to 29)
- Emax of IGF-I(Days 22 to 29)