Could a skin patch replace IV sedation? early test in healthy adults

NCT ID NCT07818330

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a skin patch that delivers dexmedetomidine, a sedative drug usually given through an IV. About 20 healthy adults will wear the patch for four consecutive 4-day periods. The study checks safety, drug levels in the blood, sedation effects, skin irritation, and how well the patch sticks to the skin.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine delivered through a skin patch
What this could lead to
If the patch works, it could offer a needle-free way to deliver a sedative medicine that is normally given through an IV.
What could go wrong
This is a small, early-stage study in healthy adults, so it cannot show whether the patch helps patients. Skin patches can cause irritation or fall off, and the drug may not reach steady levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects must be non-smokers, as defined by cessation of smoking and consumption of no more than 2 tobacco/nicotine-containing products within 6 months prior to screening. * Have a body weight \> 50 kg, and body mass index (BMI) of 18.0 to 38.0 kg/m2 * Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject's ability to wear the investigational product at the application site for the specified duration of treatment * Female subjects are eligible only if all the following apply: 1. Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter 2. Surgically sterile (via hysterectomy or oophorectomy); or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study * Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 3 months following the study. Exclusion Criteria: * History of allergy or hypersensitivity to dexmedetomidine or dexmedetomidine hydrochloride. * Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS application site, according to examination by the investigator at screening or admission to the clinic. * History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * History of seizures. * Use of any prescription or non-prescription drugs (except acceptable forms of birth control, paracetamol up to 2 g per day for no more than 3 consecutive days, and ibuprofen up to 1.2 g per day for no more than 3 consecutive days for headache or dysmenorrhea, etc., per investigator discretion) within 14 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere * Significant history of postural hypotension, or history of severe dizziness or fainting upon standing in the opinion of the investigator. * Donation of blood or loss of blood (\> 100 mL) within 30 days prior to study drug administration. * Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug

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