A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Placebo; Drug: PB 718

• Registration Number: NCT05021666
• Lead Sponsor: PegBio Co., Ltd.

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.

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Primary Completion: 2022-05-18
• Study Completion: 2022-08-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
2. Males or females, of any race, between 18 and 55 years of age, inclusive.
3. 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.
4. 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).

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Exclusion Criteria

1. 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).
2. 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.
3. 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.
4. History of multiple endocrine neoplasia type 2 or an abnormal thyroid function test (thyroid stimulating hormone, triiodothyronine, thyroxine) at Screening or Baseline.
5. Fasting plasma glucose greater than ≥126 mg/dL at Baseline.
6. Hemoglobin A1c value >6.5%
7. History of chronic or acute pancreatitis, or amylase or lipase exceeding 2 × ULN at Screening or Baseline. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group A2	Placebo	PB-718 vs placebo
Group A3	Placebo	PB-718 vs placebo
Group A1	Placebo	PB-718 vs placebo
Group A1	PB 718	PB-718 vs placebo
Group B4	PB 718	PB-718 vs placebo
Group A2	PB 718	PB-718 vs placebo
Group A3	PB 718	PB-718 vs placebo
Group A4	Placebo	PB-718 vs placebo
Group A4	PB 718	PB-718 vs placebo
Group A5	Placebo	PB-718 vs placebo
Group A5	PB 718	PB-718 vs placebo
Group A6	Placebo	PB-718 vs placebo
Group A6	PB 718	PB-718 vs placebo
Group B1	Placebo	PB-718 vs placebo
Group B1	PB 718	PB-718 vs placebo
Group B2	Placebo	PB-718 vs placebo
Group B2	PB 718	PB-718 vs placebo
Group B3	Placebo	PB-718 vs placebo
Group B3	PB 718	PB-718 vs placebo
Group B4	Placebo	PB-718 vs placebo

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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 Outcome Measures

Name	Time	Method
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.	terminal disposition phase rate constant (λz)

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Daytona Beach, Florida, United States