69 Participants NeededMy employer runs this trial

TEV-56286 for Healthy Participants

TU
Overseen ByTeva U.S. Medical Information
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TEV-56286, an experimental therapy, to understand how the body absorbs, processes, and eliminates it. The goal is to ensure safety and comfort for users. Participants will receive single or multiple doses to help researchers gather this information. Healthy individuals with a body weight of at least 50 kg for males and 45 kg for females, and no significant health issues, might be suitable for the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to contact the trial investigator for more details.

Is there any evidence suggesting that TEV-56286 is likely to be safe for humans?

Previous studies have tested TEV-56286 for treating multiple system atrophy, a disorder affecting the brain and nerves. Research so far shows that TEV-56286 is generally well-tolerated, meaning most people can take it without serious problems. Some trials continue to investigate its safety, suggesting that any side effects can be managed. Importantly, there have been no major reports of severe side effects, indicating a positive safety profile. However, since this trial is in the early stages, the main goal is to learn more about how the body handles TEV-56286 and its safety at different doses. While past results are promising, this trial aims to provide more detailed safety information.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about TEV-56286 because it offers a fresh approach to treatment by using a new active ingredient that is different from current options. Unlike existing treatments that may require multiple doses over time to be effective, TEV-56286 is being explored in both single ascending doses and multiple doses to potentially provide flexibility in administration. This novel approach could mean faster results and an improved treatment experience for patients.

What evidence suggests that TEV-56286 could be effective?

Research has shown that TEV-56286 is being tested as a treatment for Multiple System Atrophy (MSA). Some studies suggest that TEV-56286 might alleviate MSA symptoms, such as muscle stiffness and coordination problems. The U.S. FDA has granted the drug special status, recognizing its potential as a promising treatment. Although more research is needed, these early findings are encouraging.23456

Who Is on the Research Team?

TM

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D LLC

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-60, with a BMI between 18.5 and 32, and minimum weight requirements (50 kg for men, 45 kg for women). Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential. Participants should have no major health issues.

Inclusion Criteria

I am male and will use effective birth control or abstain from sex during the study.
I am healthy and my weight and BMI are within the required range for my gender.
I am between 18 and 60 years old.
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Exclusion Criteria

Alkaline phosphatase (ALP), alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 × upper limit of normal (ULN)
Participant has clinically significant diseases of renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal, immunological, endocrine, metabolic, neurological, psychiatric systems or any illness posing additional risk or confounding trial results as judged by Principal Investigator
Current smoker, smoked in last 6 months, planning to start smoking during trial, uses tobacco or nicotine-containing products, or has positive urine cotinine test
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

45 days

Single Ascending Dose

Participants receive single doses of TEV-56286 with increasing amounts to assess pharmacokinetics, safety, and tolerability

4 days
In-clinic period

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 days

Multiple Dose

Participants receive multiple doses of TEV-56286 to assess pharmacokinetics, safety, and tolerability

10 days
In-clinic period

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 days

What Are the Treatments Tested in This Trial?

Interventions

  • TEV-56286

Trial Overview

The study tests different single and multiple doses of an experimental drug called TEV-56286 compared to placebo in healthy volunteers. The goal is to see how the body processes the drug and check its safety over about two months.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Group 6: Multiple Ascending Dose (MAD2)Experimental Treatment2 Interventions
Group II: Group 5: Multiple Ascending Dose (MAD1)Experimental Treatment1 Intervention
Group III: Group 4: Single Ascending Dose (SAD4)Experimental Treatment2 Interventions
Group IV: Group 3: Single Ascending Dose (SAD3)Experimental Treatment2 Interventions
Group V: Group 2: Single Ascending Dose (SAD2)Experimental Treatment2 Interventions
Group VI: Group 1: Single Ascending Dose (SAD1)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Citations

Study Details | NCT06568237 | A Trial to Test if TEV-56286 ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...

A Trial to Test if TEV-56286 is Effective for Treatment of ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...

A Trial to Test if TEV-56286 is Effective for Treatment of ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...

TEV-56286 for Multiple System Atrophy

The study tests the long-term safety of an oral drug called TEV-56286 in treating Multiple System Atrophy over approximately 100 weeks. It aims to understand if ...

NCT07197866 | An Extension Trial to Test if TEV-56286 is ...

TEV-56286 is Effective in Relieving Multiple System Atrophy. Accepts healthy volunteers … health outcomes. trial is approximately 100 weeks.

A Trial to Test if TEV-56286 is Effective for Treatment of ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...