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

NCT05021666 | Completed Phase 1 FDA Drug

• 1 other identifier: PB718-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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.

  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.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (10)

Group A1

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group A2

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group A3

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group A4

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group A5

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group A6

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group B1

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group B2

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group B3

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Group B4

EXPERIMENTAL

PB-718 vs placebo

Drug: Placebo; Drug: PB 718

Interventions

Placebo DRUG

matching placebo

Group A1; Group A2; Group A3; Group A4; Group A5; Group A6; Group B1; Group B2; Group B3; Group B4

PB 718 DRUG

dose in the next group will be determined following a review of data from the previous group

Group A1; Group A2; Group A3; Group A4; Group A5; Group A6; Group B1; Group B2; Group B3; Group B4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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. -

Sponsors & Collaborators

• PegBio Co., Ltd.: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit Inc.

Daytona Beach, Florida, 32117, United States

Location

Study Officials

• Hugh Coleman, MD

  Daytona Beach CRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In Part A, 48 subjects will be studied in 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. In Part B, 32 subjects will be studied in 4 groups (Groups B1 to B4), with each group consisting of 8 subjects Following review of the safety, tolerability, and PK data, additional dose groups may be added to the study. Up to 3 further groups of 8 subjects (6 PB-718: 2 placebo) may be included in each of Parts A and B.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: July 29, 2020
• Primary Completion: May 18, 2022
• Study Completion: August 12, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)