This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.
Dose levels of 25 µg, 50 µg, 100 µg and 200 µg with a dosing regimen of once weekly for 4 consecutive weeks will be evaluated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
Frontage Clinical Services. Inc.
Hackensack, New Jersey, United States
the number of AEs and the finding from the physical examination, the abnormal lab results
include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory)
Time frame: accessed up to 4 weeks
PB-119 blood plasma concentration
to collect PB-119 blood plasma concentration of the subjects who use PB-119 intervention
Time frame: accessed up to 4 weeks
PB-119 antibody
the number of subjects who are with positive antibody results
Time frame: accessed up to 4 weeks
Insulin sensitivity (SI)
be estimated from glucose and insulin concentration
Time frame: accessed up to 4 weeks
Beta-cell Responsivity Index
be estimated from serum glucose and c-peptide concentrations
Time frame: accessed up to 4 weeks
Disposition Index
be calculated for each individual subject as the product of SI and Φtotal
Time frame: accessed up to 4 weeks
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