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

Sponsor

PegBio Co., Ltd. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05021666

Collaborator

Covance (Industry)

Enrollment

Location

Arms

26.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Placebo Drug: PB 718	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 29, 2020

Anticipated Primary Completion Date :

Mar 16, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A1 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group A2 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group A3 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group A4 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group A5 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group A6 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group B1 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group B2 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group B3 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group
Experimental: Group B4 PB-718 vs placebo	Drug: Placebo matching placebo Drug: PB 718 dose in the next group will be determined following a review of data from the previous group

Outcome Measures

Primary Outcome Measures

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

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.]
AUC (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration) from time zero to the time of the last quantifiable concentration (AUC0-tlast)
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.]
Cmax (maximum observed plasma concentration)
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.]
Tmax (time of the maximum observed plasma concentration)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Inc.	Daytona Beach	Florida	United States	32117

Sponsors and Collaborators

PegBio Co., Ltd.
Covance

Investigators

Principal Investigator: Hugh Coleman, MD, Daytona Beach CRU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PegBio Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05021666

Other Study ID Numbers:

PB718-001

First Posted:

Aug 25, 2021

Last Update Posted:

Sep 16, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 16, 2021