drugset / Trial / NCT04385420
Phase 1 Study of ATR-002
Phase 1
Completed
70 enrolled
Atriva Therapeutics GmbH
SGS Life Sciences, a division of SGS Belgium NV · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |