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
Overview
- Phase
- Phase 1
- Intervention
- PB 718
- Conditions
- Healthy Subjects
- Sponsor
- PegBio Co., Ltd.
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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. -
Arms & Interventions
Group A1
PB-718 vs placebo
Intervention: PB 718
Group A1
PB-718 vs placebo
Intervention: Placebo
Group A2
PB-718 vs placebo
Intervention: Placebo
Group A2
PB-718 vs placebo
Intervention: PB 718
Group A3
PB-718 vs placebo
Intervention: Placebo
Group A3
PB-718 vs placebo
Intervention: PB 718
Group A4
PB-718 vs placebo
Intervention: Placebo
Group A4
PB-718 vs placebo
Intervention: PB 718
Group A5
PB-718 vs placebo
Intervention: Placebo
Group A5
PB-718 vs placebo
Intervention: PB 718
Group A6
PB-718 vs placebo
Intervention: Placebo
Group A6
PB-718 vs placebo
Intervention: PB 718
Group B1
PB-718 vs placebo
Intervention: Placebo
Group B4
PB-718 vs placebo
Intervention: PB 718
Group B1
PB-718 vs placebo
Intervention: PB 718
Group B2
PB-718 vs placebo
Intervention: Placebo
Group B2
PB-718 vs placebo
Intervention: PB 718
Group B3
PB-718 vs placebo
Intervention: Placebo
Group B3
PB-718 vs placebo
Intervention: PB 718
Group B4
PB-718 vs placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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.
Secondary Outcomes
- 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.)