A Trial to Assess TEV-56286 at Different Doses in Healthy Participants

Part of paid clinical trials in Miramar, Florida.

Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Study ID
NCT07674940
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • TEV-56286 Dose A — DRUG
    oral administration
  • TEV-56286 Dose B — DRUG
    oral administration
  • TEV-56286 Dose C — DRUG
    oral administration
  • TEV-56286 Dose D — DRUG
    oral administration
  • TEV-56286 Dose E — DRUG
    oral administration
  • Placebo — DRUG
    matching placebo

Study Details

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 Dose is approximately 64 days; including 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.

Key Dates

First listed
Jun 30, 2026
Start date
Jun 29, 2026
Status verified
Jul 2026
Primary completion
Jan 15, 2027
Completion
Jan 22, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Group 1: Single Ascending Dose (SAD1)
  • Experimental: Group 2: Single Ascending Dose (SAD2)
  • Experimental: Group 3: Single Ascending Dose (SAD3)
  • Experimental: Group 4: Single Ascending Dose (SAD4)
  • Experimental: Group 5: Multiple Dose (MD1)

Primary Outcome Measure

SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286 [ Time Frame: Day 1 to Day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Teva Investigational Site 12174MiramarFlorida33025-

Find similar trials in Miramar, FL

By research site
Teva Investigational· Miramar, FL

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