First human tests begin for experimental drug TEV-56286
NCT ID NCT07674940
First seen Jun 30, 2026 · Last updated Sep 09, 2026 · Updated 8 times
Summary
This early-stage trial tests the safety and how the body handles TEV-56286 (also known as emrusolmin or anle138b) in healthy adults. Participants receive either single or multiple rising doses of the drug or a placebo. The study measures how the drug is absorbed, distributed, and eliminated, and monitors for any side effects. Results will help determine safe doses for future studies in people with diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TEV-56286 (emrusolmin, anle138b)
- What this could lead to
- If safe and well-tolerated, this could pave the way for future studies testing TEV-56286 as a treatment for diseases like Parkinson's or other protein-aggregation disorders.
- What could go wrong
- This is an early, first-in-human trial in healthy volunteers, so it cannot show whether the drug works for any disease. Side effects or poor tolerability may stop further development.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * 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. 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 Exclusion Criteria: * 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). * 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Teva Investigational Site 12174
RECRUITINGMiramar, Florida, 33025, United States
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