A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB-718 Following Subcutaneous Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.
详细描述
A Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB-718 following subcutaneous administration in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Investigator and other members of staff involved with the study will remain blinded to the treatment randomization code during the assembly procedure. The placebo solution will be identical in appearance to the PB-718.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •Males or females, of any race, between 18 and 55 years of age, inclusive.
- •Male subjects will weigh at least 50 kg, and female subjects will weigh at least 45 kg. Body mass index between 20.0 and 30.0 kg/m2 (Part A) or 25.0 to 50.0 kg/m2 (Part B), inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check-in/predose as assessed by the Investigator (or designee).
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular or other heart disease, gastrointestinal, urinary/prostatic, neurological, respiratory, endocrine, or psychiatric disorder, or glaucoma, as determined by the Investigator (or designee).
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •Liver disease or liver injury, as indicated by abnormal liver function tests (e.g. serum bilirubin, direct bilirubin, ALT, AST, γ-GT, or ALK exceeding the ULN) at Screening or Baseline which may be repeated for confirmation per the Investigators discretion at Screening and Check-in.
- •History of multiple endocrine neoplasia type 2 or an abnormal thyroid function test (thyroid stimulating hormone, triiodothyronine, thyroxine) at Screening or Baseline.
- •Fasting plasma glucose greater than ≥126 mg/dL at Baseline.
- •Hemoglobin A1c value >6.5%
- •History of chronic or acute pancreatitis, or amylase or lipase exceeding 2 × ULN at Screening or Baseline. -
研究组 & 干预措施
Group A1
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group A1
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A2
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A2
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group A3
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A3
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group A4
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A4
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group A5
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A5
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group A6
PB-718 vs placebo
干预措施: Placebo (Drug)
Group A6
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group B1
PB-718 vs placebo
干预措施: Placebo (Drug)
Group B4
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group B1
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group B2
PB-718 vs placebo
干预措施: Placebo (Drug)
Group B2
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group B3
PB-718 vs placebo
干预措施: Placebo (Drug)
Group B3
PB-718 vs placebo
干预措施: PB 718 (Drug)
Group B4
PB-718 vs placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.
Incidence, causality, and severity of AE. The condition of each subject will be monitored from the time of signing the ICF to Final Discharge from the study. Subjects will be observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects will also be encouraged to spontaneously report AEs occurring at any other time during the study.
次要结局
- Pharmacokinetic (PK) profile(From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.)