[E-Daily Reporter Park Sun-Yeop ] MedPacto, Inc.(235980)announced on the 15th that it has submitted a Phase 1 clinical trial protocol for its new osteoclast formation inhibitor, MP2021, to the Australian Human Research Ethics Committee (HREC).
This clinical trial will be conducted on healthy adult volunteers to evaluate the safety and tolerability of a single intravenous dose of MP2021. Pharmacokinetics, pharmacodynamics, and immunogenicity will also be assessed.
The trial is designed as a randomized, single-blind, placebo-controlled, single-dose escalation study. Up to 32 participants will be recruited and divided into up to four dose groups: 1.5 mg/kg, 3 mg/kg, and 6 mg/kg. A 9 mg/kg dose group may be added if necessary.
The clinical trial will be conducted at the Nucleus Network in Sydney, Australia. MedPacto, Inc. plans to begin the trial in the fourth quarter of this year and conduct it for approximately two years, through the fourth quarter of 2028.
This clinical trial will be conducted on healthy adult volunteers to evaluate the safety and tolerability of a single intravenous dose of MP2021. Pharmacokinetics, pharmacodynamics, and immunogenicity will also be assessed.
The trial is designed as a randomized, single-blind, placebo-controlled, single-dose escalation study. Up to 32 participants will be recruited and divided into up to four dose groups: 1.5 mg/kg, 3 mg/kg, and 6 mg/kg. A 9 mg/kg dose group may be added if necessary.
The clinical trial will be conducted at the Nucleus Network in Sydney, Australia. MedPacto, Inc. plans to begin the trial in the fourth quarter of this year and conduct it for approximately two years, through the fourth quarter of 2028.
