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New drug formulations tested in healthy volunteers

NCT ID NCT06911567

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different versions of the drug TEV-56286 (emrusolmin) in 47 healthy adults to see how well the body absorbs each form. Participants took a single dose of either a new formulation or a reference capsule, and researchers measured drug levels in the blood. The goal was to compare the formulations and check for any safety issues over about 70 days.

What this could mean

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

Active substance
Emrusolmin (TEV-56286)
What this could lead to
If successful, this could help determine the best way to deliver emrusolmin in future studies, potentially leading to better treatments for conditions it targets.
What could go wrong
This is an early-stage trial in healthy volunteers, not patients. It only measures drug levels and short-term safety, so it cannot predict if the drug will work for any disease.

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

47 people

The number who actually took part.

Started

Mar 2025

Finished

Jun 2025

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 to 60 years

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: * Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive) * Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study * Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method * NOTE - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Participation in another clinical trial simultaneously * Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study * History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine) * Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period * Donated blood or blood products (eg, white blood cells \[WBCs\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening * Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure * NOTE - Additional criteria apply, please contact the investigator for more information

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Teva Investigational Site 12141

    Miramar, Florida, 33025, United States

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