drugset / Trial / 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.

NCT06309667

Phase 1 Completed 102 enrolled ProGen. Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-03-04
Primary completion
2025-02-05
Completion
2025-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PG-102(MG12) Protein / enzyme biologic 15 mg Subcutaneous
Subject PG-102(MG12) Protein / enzyme biologic 30 mg Subcutaneous
Subject PG-102(MG12) Protein / enzyme biologic 60 mg Subcutaneous

Indications