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NCT07674940
A Trial to Assess TEV-56286 at Different Doses in Healthy Participants
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 60
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Location: Teva Investigational Site 12174 Miramar Florida
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07674940). StuddyBuddy aggregates publicly available trial information.