Phase 1 Open-Label Pharmacokinetic, Safety and Tolerability Study of a Single Subcutaneous Dose of Glymera (PB1023) Injection in Subjects With Normal Renal Function and Subjects With Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Primary objective:
To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.
Secondary objectives:
To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females age 18 - 79 years of age inclusive.
- •BMI 19 - 40 kg/m
- •Renally Impaired Subjects: In otherwise stable health except for Renal Disease.
- •Healthy volunteers must have/be: eGFR as calculated by MDRD of ≥ 80 mL/min, and Matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible BMI, race and gender.
- •Subjects with renal impairment must have 2 separate eGFR that are within 20% of each other and clinically stable for a minimum of 6 months.
- •No clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the Investigator.
排除标准
- •Currently taking or have taken a GLP -1 agent (e.g., Byetta®, Victoza®) within the past year.
- •Subjects who have previously received PB
- •Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
- •Serious Infection within 60 days of admission.
- •Donation or loss of greater than 400 mL of blood 56 days prior to enrollment.
- •Unstable cardiovascular disease defined as per protocol.
- •Clinically significant hepatic dysfunction defined as per protocol.
- •Female subjects who are pregnant, trying to become pregnant or lactating.
- •Known history of or active alcohol or drug abuse within 12 months prior to Screening or positive alcohol and/or drug screen.
- •Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.
- •Participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.
研究组 & 干预措施
Impaired Renal Function
Subjects have impaired renal function matched to subjects with normal renal function by age and weight.
干预措施: PB1023 Injection (Drug)
Normal Renal Function
Subjects have normal renal function matched to subjects with impaired renal function by age and weight.
干预措施: PB1023 Injection (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F.
次要结局
- Safety/Tolerability(Screening to Final Visit (Approximately 6 weeks))