A Study to Evaluate the Intramuscular Administration of Scopolamine
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ClinicalTrials.gov Identifier: NCT04314713 |
Recruitment Status :
Terminated
(DSMB decision due to adverse events)
First Posted : March 19, 2020
Last Update Posted : June 3, 2022
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Sponsor:
Battelle Memorial Institute
Information provided by (Responsible Party):
Battelle Memorial Institute
Tracking Information | |||||
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First Submitted Date ICMJE | March 10, 2020 | ||||
First Posted Date ICMJE | March 19, 2020 | ||||
Last Update Posted Date | June 3, 2022 | ||||
Actual Study Start Date ICMJE | June 2, 2020 | ||||
Actual Primary Completion Date | April 6, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Determine degree and number of adverse events experienced by subjects. [ Time Frame: 30 Days (+7) ] To characterize the safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Determine what the what the body does with the movement of drug within the body of Scopolamine HBT after IM Administration. [ Time Frame: 30 Days (+7) ] A goal of this clinical study is to measure Scopolamine HBT immunity remaining in each participant after IM administration. The predicted efficacious Cmax, based on limited nonclinical studies, is 16-18 ng/mL. At the end of each cohort, the PI, DSMB, and sponsor will evaluate the safety outcomes and PK data associated with the Scopolamine HBT dosing for that group.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Intramuscular Administration of Scopolamine | ||||
Official Title ICMJE | A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluated The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection | ||||
Brief 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: double-blinded, randomized, placebo-controlled Primary Purpose: Prevention
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Condition ICMJE | Scopolamine Causing Adverse Effects in Therapeutic Use | ||||
Intervention ICMJE | Drug: Scopolamine Hydrobromide Trihydrate
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
32 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Actual Study Completion Date ICMJE | May 6, 2021 | ||||
Actual Primary Completion Date | April 6, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04314713 | ||||
Other Study ID Numbers ICMJE | S-16-14 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Battelle Memorial Institute | ||||
Original Responsible Party | U.S. Army Medical Research and Development Command | ||||
Current Study Sponsor ICMJE | Battelle Memorial Institute | ||||
Original Study Sponsor ICMJE | U.S. Army Medical Research and Development Command | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Battelle Memorial Institute | ||||
Verification Date | May 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |