A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.
研究概览
简要总结
The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.
详细描述
This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give informed consent
- •Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
- •Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
- •Body mass index of 18-35 kg/m2
- •Be C-peptide deficient (assessed by fasting concentration level)
- •Normal renal function (assessed by serum creatinine)
- •Be in good general health (besides T1DM)
- •Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)
排除标准
- •Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
- •Unstable glucose control
- •Have had a islet cell, kidney, and/or pancreas transplant
- •Blood loss or blood donation within 56 days
- •Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
- •History or positive test result for Hepatitis B, C, and/or HIV
- •Treatment with medication for peripheral neuropathy within 30 days
研究组 & 干预措施
CBX129801
干预措施: CBX129801 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.
时间窗: For duration of study / 16 months
Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.
时间窗: For duration of study / 16 months
次要结局
- To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.(Predose and 6 and 12 weeks postdose)
- To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.(Predose and 6 and 12 weeks postdose)
- To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.(For duration of study / 16 months)
- To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)(Predose and 12 weeks postdose)