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Completed
NCT05408091
Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 16
Sponsor: Trellis Bioscience LLC
Location: Celerion Tempe Arizona
Summary
This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients.
Eligibility Criteria
Inclusion Criteria:
1. Healthy male and non-pregnant, non-breast-feeding female subjects at between 18 and 65 years of age, inclusive, and representative of the general population
2. Willing and able to provide written informed consent.
3. Availability for the entire duration of the study, and willingness to adhere to protocol requirements
4. In good health, as determined by lack of clinically significant abnormalities in health assessments performed at the Screening Visit, as judged by the Principal Investigator (PI) or as delegated by the PI to a physician or nurse practitioner as sub-investigator.
5. Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, or intrauterine device (IUD) for 28 days before Screening and through Day 76. Men must also refrain from donating sperm from Day 1 through Day 76.
Exclusion Criteria:
1. Inability to tolerate blood draws or has poor venous access
2. Body mass index (BMI) \
Source: ClinicalTrials.gov (NCT05408091). StuddyBuddy aggregates publicly available trial information.