Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05249621 | A Randomized Phase 1 of of MZE001 in Healthy Volunteers | PHASE1 | COMPLETED | 121 | — | — | Feb 7, 2022 | Dec 21, 2022 | Feb 6, 2023 | 1 | United States |
Occurrence of adverse events, serious adverse events, adverse events of special interest
| Arm | Type | Description |
|---|---|---|
| MZE001 | EXPERIMENTAL | MZE001 is a small molecule inhibitor of muscle glycogen synthase for the potential treatment of Pompe disease. |
| Placebo | PLACEBO_COMPARATOR | Excipients containing no active ingredients. |
| Name | Type | Description |
|---|---|---|
| MZE001 | DRUG | Small molecule inhibitor of muscle glycogen synthase |
| Placebo | DRUG | Product containing excipients with no active ingredients |
Inclusion Criteria: 1. Male and female subjects, ages 18 - 55 years, inclusive; 2. Must provide written informed consent prior to any study assessments and be willing and able to comply with all study procedures; 3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive; 4. Healthy as determin...