Safety, tolerability, pharmacokinetics, and pharmacodynamics of oral JMKX003002 in Chinese healthy participants: a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose, and food-effect phase I clinical trial.

In 30 seconds

This phase I randomized, double-blind, placebo-controlled trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002, an NHE3 inhibitor, in healthy Chinese participants. The study found that JMKX003002 was well-tolerated, with mild adverse events, and significantly increased stool sodium and phosphorus excretion compared to baseline.

Key findings

• JMKX003002 was well-tolerated, with mostly mild treatment-related adverse events.
• One Grade 3 diarrhoea occurred in both the 50 mg and 125 mg groups.
• 79.9% of JMKX003002 was recovered in stool, indicating low systemic exposure.
• Significant food effect on stool sodium and phosphorus excretion was observed.

Why it matters

Understanding the safety and pharmacodynamics of JMKX003002 is crucial for evaluating its potential therapeutic role in managing conditions related to sodium and phosphorus balance, which may impact gastrointestinal health.