drugset / Trial / NCT04314713
A Study to Evaluate the Intramuscular Administration of Scopolamine
RandomizedParallel-groupTriple-blindPrevention
Summary
To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection. And characterize the pharmacokinetics (PK) of ascending doses of Scopolamine HBT administered by IM injection
Timeline
- Start
- 2020-06-02
- Primary completion
- 2021-04-06
- Completion
- 2021-05-06
Outcome
Outcome not reported
Stopped: “DSMB decision due to adverse events”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Scopolamine | Unknown | 0.005 mg/kg | Intramuscular |
| Comparator | Scopolamine | Unknown | 0.007 mg/kg | Intramuscular |
| Comparator | Scopolamine | Unknown | 0.011 mg/kg | Intramuscular |
| Comparator | Scopolamine | Unknown | 0.014 mg/kg | Intramuscular |
| Comparator | Scopolamine | Unknown | 0.021 mg/kg | Intramuscular |