Healthy VolunteersPhase 1NCT07674940
A Trial to Assess TEV-56286 at Different Doses in Healthy Participants
A Phase 1 study testing TEV-56286 in people with Healthy Volunteers, run by Teva Branded Pharmaceutical Products R&D LLC at 1 site in United States.
Trial summary
The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses. The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TEV-56286
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to 22 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg/m2 inclusive.
- Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).
- Female participants are eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
- A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).
- A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), used consistently and correctly. The acceptable contraceptive regimens in this trial are: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP), bilateral tubal occlusion, and/or azoospermic partner (vasectomized or due to a medical cause). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.
- Male participants are eligible to participate if they are azoospermic (vasectomized or due to a medical cause) or, alternatively, agree to the following during the trial period, from admission (day -1) and for at least 28 days after last dose of IMP.
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- Refrain from donating sperm, in addition to following:
- EITHER be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- OR must agree to use contraception/barrier as detailed below:
- Agree to use a male condom with female partner using an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant.
- Agree to use a male condom when having sexual intercourse with a pregnant partner.
- NOTE-Additional criteria apply, please contact the investigator for more information
Who cannot join
- Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence/history of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.
- Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.
- The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).
- Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.
- Participant has a personal or family history of arrhythmia, long QT syndrome, or sudden unexplained death in a first-degree relative before the age of 40; or personal history of syncope, myocardial infarction, cerebrovascular accident, or previous treatment for high blood pressure (BP).
- Participant has an alkaline phosphatase (ALP), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), or total bilirubin above the upper limit of normal (ULN).
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- Participant has a history of alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association 2013) or are unwilling to comply with the restricted food or beverages during the trial.
- Participant is a current smoker, has smoked in the last 6 months, is planning to start smoking during the trial, uses tobacco, or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, e-cigarettes, vaping devices, inhalers), or has a positive urine cotinine test.
- NOTE-Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Teva Investigational Site 12174
Miramar, Florida, 33025
About this study
Official title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses
The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.
The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.
Read more
A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.
The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
The estimated duration for participants in Part 2 with Multiple Ascending Dose is approximately 64 days; including up to 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
- Conditions
- Healthy Volunteers
- Being tested
- TEV-56286, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-56286Drug
Also called emrusolmin, anle138b
oral administration
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Single Ascending Dose (SAD1) | Experimental | Not described Receives: Drug: TEV-56286; Drug: Placebo |
| Group 2: Single Ascending Dose (SAD2) | Experimental | Not described Receives: Drug: TEV-56286; Drug: Placebo |
| Group 3: Single Ascending Dose (SAD3) | Experimental | Not described Receives: Drug: TEV-56286; Drug: Placebo |
| Group 4: Single Ascending Dose (SAD4) | Experimental | Not described Receives: Drug: TEV-56286; Drug: Placebo |
| Group 5: Multiple Ascending Dose (MAD1) | Experimental | Not described Receives: Drug: TEV-56286 |
| Group 6: Multiple Ascending Dose (MAD2) | Experimental | Not described Receives: Drug: TEV-56286; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286
Measured: Day 1 to Day 3
SAD: Maximum observed plasma concentration (Cmax) of TEV-56286
Measured: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of TEV-56286
Measured: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of TEV-56286
Measured: Day 1 to Day 3
MAD: tmax of TEV-56286
Measured: Day 7 to Day 9
MAD: Cmax of TEV-56286
Measured: Day 7 to Day 9
MAD: AUC0-t of TEV-56286
Measured: Day 7 to Day 9
MAD: Area Under the Plasma Drug Concentration-Time Curve for the Defined Interval Between Doses (AUC0-tau) of TEV-56286
Measured: Day 7 to Day 8
Secondary outcomes (2)
Number of participants with at least 1 treatment-emergent adverse event
Measured: Up to Day 17
Number of participants who did not complete the trial due to an adverse event
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start26 Jun 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
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
- NCT07674940
- Sponsor's protocol ID
- TV56286-PK-10202
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses
- ClinicalTrials.gov ID
- NCT07674940
- Acronym / sponsor ID
- TV56286-PK-10202
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 30 Jun 2026 (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 purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.
The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.
A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.
The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
The estimated duration for participants in Part 2 with Multiple Ascending Dose is approximately 64 days; including up to 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Single Ascending Dose (SAD1) | Experimental | Drug: TEV-56286, Drug: Placebo |
| Group 2: Single Ascending Dose (SAD2) | Experimental | Drug: TEV-56286, Drug: Placebo |
| Group 3: Single Ascending Dose (SAD3) | Experimental | Drug: TEV-56286, Drug: Placebo |
| Group 4: Single Ascending Dose (SAD4) | Experimental | Drug: TEV-56286, Drug: Placebo |
| Group 5: Multiple Ascending Dose (MAD1) | Experimental | Drug: TEV-56286 |
| Group 6: Multiple Ascending Dose (MAD2) | Experimental | Drug: TEV-56286, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg/m2 inclusive.
- Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).
- Female participants are eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
- A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).
- A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), used consistently and correctly. The acceptable contraceptive regimens in this trial are: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP), bilateral tubal occlusion, and/or azoospermic partner (vasectomized or due to a medical cause). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.
Key exclusion criteria (9 listed)
- Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence/history of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.
- Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.
- The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).
- Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.
- Participant has a personal or family history of arrhythmia, long QT syndrome, or sudden unexplained death in a first-degree relative before the age of 40; or personal history of syncope, myocardial infarction, cerebrovascular accident, or previous treatment for high blood pressure (BP).
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-56286Also: emrusolmin, anle138boral administration | Drug | Group 1: Single Ascending Dose (SAD1), Group 2: Single Ascending Dose (SAD2), Group 3: Single Ascending Dose (SAD3), Group 4: Single Ascending Dose (SAD4), Group 5: Multiple Ascending Dose (MAD1), Group 6: Multiple Ascending Dose (MAD2) |
| Placebomatching placebo | Drug | Group 1: Single Ascending Dose (SAD1), Group 2: Single Ascending Dose (SAD2), Group 3: Single Ascending Dose (SAD3), Group 4: Single Ascending Dose (SAD4), Group 6: Multiple Ascending Dose (MAD2) |
Primary outcome
SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286
Time frame: Day 1 to Day 3
SAD: Maximum observed plasma concentration (Cmax) of TEV-56286
Time frame: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of TEV-56286
Time frame: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of TEV-56286
Time frame: Day 1 to Day 3
MAD: tmax of TEV-56286
Time frame: Day 7 to Day 9
MAD: Cmax of TEV-56286
Time frame: Day 7 to Day 9
MAD: AUC0-t of TEV-56286
Time frame: Day 7 to Day 9
MAD: Area Under the Plasma Drug Concentration-Time Curve for the Defined Interval Between Doses (AUC0-tau) of TEV-56286
Time frame: Day 7 to Day 8
2 secondary outcomes
Number of participants with at least 1 treatment-emergent adverse event
Time frame: Up to Day 17
Number of participants who did not complete the trial due to an adverse event
Time frame: Up to Day 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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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.
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 in people with Healthy Volunteers, 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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teva U.S. Medical Information (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286 (time frame: Day 1 to Day 3). The study lists 8 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 8 Sep 2026.