This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants. This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.
Part A (SAD): In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects. Part B (MAD): In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects. Part C (MAD): In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
GLP-1 and GLP-2 fusion protein
Placebo drug of PG-102(MG12)
Catholic University Seoul St.Mary Hospital,
Seocho, Seoul, South Korea
Number of participants with treatment-emergent adverse events (TEAEs) for Part A
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Day 29
Number of participants with treatment-emergent adverse events (TEAEs) for Part B
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Day 57
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline to Day 29
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline to Day 57
Number of participants with clinically significant abnormalities in vital signs for Part A
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Time frame: Baseline to Day 29
Number of participants with clinically significant abnormalities in vital signs for Part B
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Time frame: Baseline to Day 57
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Time frame: Baseline to Day 29
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Time frame: Baseline to Day 57
Maximum plasma concentration (Cmax) for Part A
Maximum plasma concentration (Cmax)
Time frame: Baseline to Day 29
Maximum plasma concentration (Cmax) for Part B
Maximum plasma concentration (Cmax)
Time frame: Baseline to Day 57
Time to maximum plasma concentration (tmax) for Part A
Time to maximum plasma concentration (tmax)
Time frame: Baseline to Day 29
Time to maximum plasma concentration (tmax) for Part B
Time to maximum plasma concentration (tmax)
Time frame: Baseline to Day 57
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Time frame: Baseline to Day 29
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Time frame: Baseline to Day 57
Terminal half-life (t1/2) for Part A
Terminal half-life (t1/2)
Time frame: Baseline to Day 29
Terminal half-life (t1/2) for Part B
Terminal half-life (t1/2)
Time frame: Baseline to Day 57
Apparent total clearance (CL/F) for Part A
Apparent total clearance (CL/F)
Time frame: Baseline to Day 29
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Apparent total clearance (CL/F) for Part B
Apparent total clearance (CL/F)
Time frame: Baseline to Day 57