NCT06309667

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: ProGen. Co., Ltd. · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy
• Overweight

Interventions

Type	Name	Description
DRUG	PG-102(MG12)	GLP-1 and GLP-2 fusion protein
OTHER	Placebo	Placebo drug of PG-102(MG12)

Timeline

• Start date: 2024-03-04
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2024-03-13
• Last updated: 2025-05-06

Locations

1 site across 1 country: South Korea