Medical CountermeasuresPhase 1NCT04314713
A Study to Evaluate the Intramuscular Administration of Scopolamine
A Phase 1 study testing Scopolamine Hydrobromide Trihydrate in people with Medical Countermeasures and Organophosphate Poisoning, run by Battelle Memorial Institute at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Countermeasures, Organophosphate Poisoning
- What is being tested?
- Scopolamine Hydrobromide Trihydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2020to 6 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 55 years of age, inclusive, at the time of drug administration
- Without clinically significant abnormities on physical examination at screening or prior to drug administration
- Generally healthy, as determined by medical history review, physical examination, and laboratory testing at screening and prior to drug administration
- Must have a BMI (body mass index) of ≥ 19.0 and ≤ 30.0, and weight range of 55.0 to 85.0 kg at screening or prior to drug administration
- Must have adequate venous access and sufficient upper leg muscle tissue for drug administration
- If female, the subject must be nonpregnant and nonbreastfeeding, and have a negative serum pregnancy test at screening and prior to drug administration
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- If female of childbearing potential, the subject must have been using adequate contraception (as defined in Section 5.3.1.5) for at least 3 months prior to drug administration and must agree to use an adequate method of contraception for at least 30 days following drug administration
- Females of nonchildbearing potential are also eligible, defined as a subject who is postmenopausal (continuous amenorrhea for 24 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy)
- A male with a female partner of childbearing potential must agree to use a barrier method of contraception (defined as condoms with spermicide) for at least 30 days following drug administration
- If male, must not have past diagnoses of benign prostatic hypertrophy or urinary tract obstruction and must not have on screening history/review of systems symptoms suggestive of urinary tract obstruction (eg, urinary hesitancy, urgency, frequency, or nocturia)
- Nonsmoker/tobacco/nicotine product (including e-cigarettes) user within 3 months of first dosing and must have a total lifetime exposure to cigarettes of < 15 pack-years
- No evidence of significant neuropsychiatric disorders based on the Brief Psychiatric Rating Scale (BPRS) at screening and prior to drug administration, which is defined as having a global score of ≤ 25 with no score higher than 2 on any one item, with the exception of a score of 1 (ie, Not Present) to disorientation, hallucinatory behavior, and suspiciousness (ie, paranoia)
- No evidence of suicidal ideation or behavior at screening and prior to drug administration, which is defined as having a global score of 0 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Ability to read, speak, and comprehend English and a willingness to sign informed consent
Who cannot join
- Received any other investigational drug within 30 days prior to drug administration
- Known allergies to any component of the study drug, other belladonna alkaloids, or the recovery medications (physostigmine, atropine, or benzodiazepines [diazepam or lorazepam])
- History of migraine headaches or seizures
- History of psychosis or psychotic episodes
- Clinically relevant abnormal physical findings (including vital signs) as determined by the investigator at screening or prior to drug administration that could interfere with the objectives of the study or the safety of the subject
- Has ongoing drug abuse/dependence (including alcohol), recent history (over the past 5 years) of treatment for alcohol or drug abuse, or a current positive alcohol breathalyzer test or current positive urine test for drugs of abuse (as defined in Section 11.1.9.5) at screening or prior to drug administration
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- Has consumed Seville orange (bitter orange), grapefruit, grapefruit juice, other grapefruit-containing products, or starfruit within 7 days prior to dosing
- Has consumed caffeine or other xanthine-containing products within 7 days prior to dosing
- Has any specified laboratory values (eg, hematology, serum chemistry, and urinalysis) outside of the normal range for age and sex and deemed clinically significant by the investigator within 30 days before drug administration
- Has positive (reactive) test results for hepatitis B surface antigen, hepatitis C, syphilis, HIV-1, or HIV-2
- Has narrow-angle glaucoma or high intraocular pressures in either or both eyes
- Has pyloric obstruction or urinary bladder neck obstruction
- Has impaired liver or kidney functions
- Clinically relevant electrocardiogram (ECG) abnormalities on any 12-lead ECG obtained at screening or prior to dosing
- ECG with a PR interval ≥ 200 msec at screening or prior to dosing
- ECG with QRS duration > 120 msec at screening or prior to dosing
- ECG RR interval > 1500 msec at screening or prior to dosing
- ECG with a QTc interval > 450 msec for males or 470 msec for females (QT interval corrected with Fridericia correction [QTcF]) at screening or prior to dosing
- Systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg at screening or prior to dosing
- Systolic blood pressure < 90 mm Hg and/or diastolic blood pressure < 50 mm Hg at screening or prior to dosing
- Currently taking or has taken other antimuscarinic drugs such as phenothiazines, tricyclic antidepressants, antihistamines (including meclizine), meperidine, or other anticholinergics that have weak antimuscarinic activity or that cause drowsiness, including antidepressants, benzodiazepines, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants within 72 hours prior to dosing
- Has taken, within 14 days of planned dosing, any prescription or nonprescription medication (including home remedies, herbal supplements, or nutritional supplements) unless the PI/subinvestigator, in consultation with the medical monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescriptions drugs will be grounds for exclusion)
- History of major DSM-5 Axis I or II disorder, or evidence of such disorder at Day -1 as determined via the Structured Clinical Interview for DSM-5, customized Clinical Trials version (SCID-5-CT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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
- Being tested
- Scopolamine Hydrobromide Trihydrate
- Keywords
- Scopolamine
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scopolamine Hydrobromide TrihydrateDrug
Scopolamine Hydrobromide Trihydrate Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Scopolamine HBT 0.005 mg/kg | Placebo comparator | Dose of Scopolamine 0.005mg/kg verses Placebo Receives: Drug: Scopolamine Hydrobromide Trihydrate |
| Scopolamine HBT 0.007 mg/kg | Placebo comparator | Dose of Scopolamine 0.007mg/kg verses Placebo Receives: Drug: Scopolamine Hydrobromide Trihydrate |
| Scopolamine HBT 0.011 mg/kg | Placebo comparator | Dose of Scopolamine 0.011mg/kg verses Placebo Receives: Drug: Scopolamine Hydrobromide Trihydrate |
| Scopolamine HBT 0.014 mg/kg | Placebo comparator | Dose of Scopolamine 0.014mg/kg verses Placebo Receives: Drug: Scopolamine Hydrobromide Trihydrate |
| Scopolamine HBT 0.021 mg/kg | Placebo comparator | Dose of Scopolamine 0.021mg/kg verses Placebo Receives: Drug: Scopolamine Hydrobromide Trihydrate |
| Placebo | No intervention | Placebo controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Degree and Number of Adverse Events Experienced by Subjects.
Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
Measured: 30 Days (+7)
Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Cmax of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Tmax of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Apparent Volume of Distribution (mL/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
t1/2 (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Apparent Clearance (mL/hr/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
MRT (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUClast (hr*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUCinfinity (hr*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Cmax/Dose (ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Measured: 30 Days (+7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start2 Jun 2020
- Primary completion6 Apr 2021
- Study completion6 May 2021
Why it stopped: DSMB decision due to adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medical CountermeasuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo DePetrillo, MD, Principal investigator, Pharmaron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314713
- Sponsor's protocol ID
- S-16-14
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2020
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04314713
- Acronym / sponsor ID
- S-16-14
- Conditions
- Medical Countermeasures, Organophosphate Poisoning
- Keywords
- Scopolamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB decision due to adverse events
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Scopolamine HBT 0.005 mg/kg | Placebo comparator | Drug: Scopolamine Hydrobromide TrihydrateDose of Scopolamine 0.005mg/kg verses Placebo |
| Scopolamine HBT 0.007 mg/kg | Placebo comparator | Drug: Scopolamine Hydrobromide TrihydrateDose of Scopolamine 0.007mg/kg verses Placebo |
| Scopolamine HBT 0.011 mg/kg | Placebo comparator | Drug: Scopolamine Hydrobromide TrihydrateDose of Scopolamine 0.011mg/kg verses Placebo |
| Scopolamine HBT 0.014 mg/kg | Placebo comparator | Drug: Scopolamine Hydrobromide TrihydrateDose of Scopolamine 0.014mg/kg verses Placebo |
| Scopolamine HBT 0.021 mg/kg | Placebo comparator | Drug: Scopolamine Hydrobromide TrihydrateDose of Scopolamine 0.021mg/kg verses Placebo |
| Placebo | No intervention | –Placebo controlled |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female, 18 to 55 years of age, inclusive, at the time of drug administration
- Without clinically significant abnormities on physical examination at screening or prior to drug administration
- Generally healthy, as determined by medical history review, physical examination, and laboratory testing at screening and prior to drug administration
- Must have a BMI (body mass index) of ≥ 19.0 and ≤ 30.0, and weight range of 55.0 to 85.0 kg at screening or prior to drug administration
- Must have adequate venous access and sufficient upper leg muscle tissue for drug administration
Key exclusion criteria (23 listed)
- Received any other investigational drug within 30 days prior to drug administration
- Known allergies to any component of the study drug, other belladonna alkaloids, or the recovery medications (physostigmine, atropine, or benzodiazepines [diazepam or lorazepam])
- History of migraine headaches or seizures
- History of psychosis or psychotic episodes
- Clinically relevant abnormal physical findings (including vital signs) as determined by the investigator at screening or prior to drug administration that could interfere with the objectives of the study or the safety of the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scopolamine Hydrobromide TrihydrateScopolamine Hydrobromide Trihydrate Intramuscular Injection | Drug | Scopolamine HBT 0.005 mg/kg, Scopolamine HBT 0.007 mg/kg, Scopolamine HBT 0.011 mg/kg, Scopolamine HBT 0.014 mg/kg, Scopolamine HBT 0.021 mg/kg |
Primary outcome
Determine Degree and Number of Adverse Events Experienced by Subjects.
Time frame: 30 Days (+7)
Safety and tolerability profile of ascending doses of scopolamine hydrobromide trihydrate (Scopolamine HBT) administered by intramuscular (IM) injection
Cmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
Cmax of ascending doses of Scopolamine HBT administered by IM injection.
Tmax of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
Tmax of ascending doses of Scopolamine HBT administered by IM injection.
Apparent Volume of Distribution (mL/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
Apparent Volume of Distribution (mL/kg) of ascending doses of Scopolamine HBT administered by IM injection.
t1/2 (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
t1/2 (hr) of ascending doses of Scopolamine HBT administered by IM injection.
Apparent Clearance (mL/hr/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
Apparent Clearance (mL/hr/kg) of ascending doses of Scopolamine HBT administered by IM injection.
MRT (hr) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
MRT (hr) of ascending doses of Scopolamine HBT administered by IM injection.
AUClast (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
AUClast (hr*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
AUCinfinity (hr*ug/mL) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
AUCinfinity (hr*ug/mL) of ascending doses of Scopolamine HBT administered by IM injection.
Cmax/Dose (ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
Cmax/Dose (ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of Ascending Doses of Scopolamine HBT Administered by IM Injection.
Time frame: 30 Days (+7)
AUCinfinity/Dose (hr*ug/mL)/(mg/kg) of ascending doses of Scopolamine HBT administered by IM injection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo DePetrillo, MD principal investigator
Pharmaron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Scopolamine Hydrobromide Trihydrate in people with Medical Countermeasures and Organophosphate Poisoning, run by Battelle Memorial Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Degree and Number of Adverse Events Experienced by Subjects. (time frame: 30 Days (+7)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.