drugset / Trial / NCT07674940

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

NCT07674940 ↗

Phase 1 Recruiting 60 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedSequentialDouble-blindOther

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 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.

Timeline

Start
2026-06-29
Primary completion
2027-01-15
Completion
2027-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject TEV-56286 Unknown — Oral

Indications

No indication recorded.