Healthy ParticipantsPhase 1NCT06911567
A Study to Assess New Formulations of TEV-56286
A Phase 1 study testing TEV-56286 Test and TEV-56286 Reference in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D LLC at 1 site in United States.
Trial summary
The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants. The secondary objective is to evaluate the safety and tolerability of TEV-56286. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- TEV-56286 Test and TEV-56286 Reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 2 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Teva Investigational Site 12141
Miramar, Florida, 33025
About this study
Official title: An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants
The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
- Conditions
- Healthy Participants
- Being tested
- TEV-56286 Test, TEV-56286 Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-56286 TestDrug
Also called Emrusolmin
Administered orally
TEV-56286 ReferenceDrug
Also called Emrusolmin
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Random sequence of test and reference formulations Receives: Drug: TEV-56286 Test; Drug: TEV-56286 Reference |
| Cohort 2 | Experimental | Random sequence of test and reference formulations Receives: Drug: TEV-56286 Test; Drug: TEV-56286 Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Drug Concentration (Cmax)
Measured: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]
Measured: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]
Measured: Up to Day 17
Secondary outcomes (2)
Number of participants with at least one treatment-emergent adverse event
Measured: Up to Day 26
Number of participants who did not complete the trial due to an adverse event
Measured: Up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start10 Mar 2025
- Primary completion22 May 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Teva Branded Pharmaceutical Products R&D LLCThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911567
- Sponsor's protocol ID
- TV56286-BA-10218
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT06911567
- Acronym / sponsor ID
- TV56286-BA-10218
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.
The secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned duration for each participant is approximately 70 days which includes a 45 day screening period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TEV-56286 Test, Drug: TEV-56286 ReferenceRandom sequence of test and reference formulations |
| Cohort 2 | Experimental | Drug: TEV-56286 Test, Drug: TEV-56286 ReferenceRandom sequence of test and reference formulations |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| TEV-56286 TestAlso: EmrusolminAdministered orally | Drug | Cohort 1, Cohort 2 |
| TEV-56286 ReferenceAlso: EmrusolminAdministered orally | Drug | Cohort 1, Cohort 2 |
Primary outcome
Maximum Observed Drug Concentration (Cmax)
Time frame: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]
Time frame: Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]
Time frame: Up to Day 17
2 secondary outcomes
Number of participants with at least one treatment-emergent adverse event
Time frame: Up to Day 26
Number of participants who did not complete the trial due to an adverse event
Time frame: Up to Day 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- 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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
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 TEV-56286 Test and TEV-56286 Reference in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D LLC 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Observed Drug Concentration (Cmax) (time frame: Up to Day 17). The study lists 3 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 9 Feb 2026.