Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05408091

Run by

Trellis Bioscience LLC

People needed

16

Starts

2023-09-14

Expected to finish

2024-12-23

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Willing and able to provide written informed consent.
• Availability for the entire duration of the study, and willingness to adhere to protocol requirements
• 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.
• 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.

You may not qualify if…

• Inability to tolerate blood draws or has poor venous access
• Body mass index (BMI) <18.5 or ≥35 kg/m2
• Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg; diastolic blood pressure lower than 50 or over 100 mmHg; or, heart rate less than 45 or over 100 bpm) at the Screening Visit
• ECG with clinically significant findings, including:
• Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS ≥120 msec, PR interval ≥220 msec, any second- or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Fridericia's correction [>450 msec male and >460 msec female])
• Significant repolarization (ST-segment or T-wave) abnormality; or
• Significant atrial or ventricular arrhythmia; or
• Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row); or
• ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction.
• Presence of any gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting),or progressive liver or kidney disease
• Diagnosis of diabetes mellitus
• History of acute or chronic pancreatitis or upper right quadrant postprandial discomfort or pain within the last 2 years
• Clinically relevant medical conditions that, in the opinion of the PI, may interfere with the evaluation of the trial drug, e.g., progressive cardiovascular disease
• Concurrent acute or chronic infections (e.g., viral infections, except chronic recurrent herpes simplex infections)
• Significant abnormal safety labs, defined as:
• Greater than 30% outside of the normal range for any of the following: hemoglobin, white blood cell (WBC) count, platelet count, neutrophil count and blood urea nitrogen
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), direct bilirubin or indirect bilirubin >2 × the upper limit of normal
• Activated partial thromboplastin time (aPTT) prolongation >1.5 x ULN
• Hemoglobin A1C (HbA1C) >5.6%
• Fasting glucose level of ≥100 mg/dl (5.6 mmol/L)
• Renal function based on the, i.e., estimated creatinine clearance < 70 mL/min (Cockcroft-Gault formula using ideal body weight)
• Hemoglobin ≤ 128 g/L (males) and ≤ 115 g/L (females), and hematocrit ≤ 37% (males) and ≤ 32.0% for females
• Positive test results for HIV, Hepatitis B (HBsAg), or Hepatitis C (HCV) at the Screening Visit
• History of significant drug abuse within one year prior to the Screening Visit and/or ongoing
• History of significant alcohol abuse within one year prior to the Screening Visit defined as more than fourteen units of alcohol per week [one "unit" is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits)

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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