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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-08-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Group A1

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group A2

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group A3

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group A4

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group A5

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group A6

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group B1

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group B2

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group B3

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Group B4

PB-718 vs placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo

PB 718

Intervention Type DRUG

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

Interventions

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Placebo

matching placebo

Intervention Type DRUG

PB 718

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

Intervention Type DRUG

Eligibility Criteria

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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).

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. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes