Catholic University Seoul St.Mary Hospital,
Seocho, Seoul, 06591, South Korea
NCT Number: NCT06309667
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.
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Notify Me19 year–65 year
All sexes
Interventional
Phase 1
Seocho, Seoul, 06591, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
[Exclusion Criteria]
GLP-1 and GLP-2 fusion protein
Placebo drug of PG-102(MG12)
Time frame: Baseline to Day 29
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Day 57
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Day 29
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline to Day 57
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline to Day 29
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Time frame: Baseline to Day 57
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Time frame: Baseline to Day 29
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Time frame: Baseline to Day 57
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Time frame: Baseline to Day 29
Maximum plasma concentration (Cmax)
Time frame: Baseline to Day 57
Maximum plasma concentration (Cmax)
Time frame: Baseline to Day 29
Time to maximum plasma concentration (tmax)
Time frame: Baseline to Day 57
Time to maximum plasma concentration (tmax)
Time frame: Baseline to Day 29
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Time frame: Baseline to Day 57
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Time frame: Baseline to Day 29
Terminal half-life (t1/2)
Time frame: Baseline to Day 57
Terminal half-life (t1/2)
Time frame: Baseline to Day 29
Apparent total clearance (CL/F)
Time frame: Baseline to Day 57
Apparent total clearance (CL/F)
ProGen. Co., Ltd.
Other
A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and 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 and Obesity Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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