drugset / Trial / NCT04385420

Phase 1 Study of ATR-002

NCT04385420

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was a combination of a single ascending dose (SAD) study to evaluate the safety, tolerability, and PK of 3 oral doses of a MEK inhibitor and a multiple ascending dose (MAD) study of 3 oral doses of a MEK inhibitor. Subjects were to be enrolled in 3 different cohorts in the SAD and 3 different cohorts in the MAD and were to be randomly (blinded) allocated to active treatment or placebo (each cohort consisted of 8 subjects receiving active treatment and 2 subjects receiving placebo).

Timeline

Start
2019-04-24
Primary completion
2019-08-26
Completion
2019-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject ZAPNOMETINIB Small molecule 100 mg Oral
Subject ZAPNOMETINIB Small molecule 300 mg Oral
Subject ZAPNOMETINIB Small molecule 600 mg Oral
Subject ZAPNOMETINIB Small molecule 900 mg Oral

Indications