NCT04314713

A Study to Evaluate the Intramuscular Administration of Scopolamine

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluate The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Battelle Memorial Institute · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a double-blinded, randomized, placebo-controlled, in-clinic, Phase 1, single-dose, IM, sequential dose-escalation study in healthy adults aged 18-55. Healthy volunteers will be assigned to 1 of 5 cohorts of Scopolamine HBT dosage groups: 0.005, 0.007, 0.011, 0.014, or 0.021 mg/kg, or will receive the placebo administered by IM injection to the anterior thigh. In each cohort, 6 to 9 subjects will receive active drug and 2 to 3 subjects will receive placebo. Each cohort will have at least 3 male and 3 female subjects enrolled among the first 8 subjects in the dosing group to ensure that at least 1 male subject and 1 female subject in each dosing group receive active drug. If nonextreme dose-limiting toxicities are observed in any of the cohorts, 4 additional subjects, 3 active and 1 placebo, may be added to each cohort.

Conditions

• Medical Countermeasures
• Organophosphate Poisoning

Interventions

Type	Name	Description
DRUG	Scopolamine Hydrobromide Trihydrate	Scopolamine Hydrobromide Trihydrate Intramuscular Injection

Timeline

• Start date: 2020-06-02
• Primary completion: 2021-04-06
• Completion: 2021-05-06
• First posted: 2020-03-19
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study