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

PegBio

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: PB 718

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05021666

PB718-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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82 participants in 10 patient groups

Group A1

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group A2

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group A3

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group A4

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group A5

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group A6

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group B1

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group B2

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group B3

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718

Group B4

Experimental group

Description:

PB-718 vs placebo

Treatment:

Drug: Placebo

Drug: PB 718