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
Teva Branded Pharmaceutical Products R&D LLC
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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 salp…