Phase 1
N=16
Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05408091 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Incidence of Abnormal Physical Exam Findings — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TRL345, a human monoclonal antibody (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trellis Bioscience LLC
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Abnormal Physical Exam Findings |
0; 0; 0 | — |
| PRIMARY Severity of Abnormal Physical Exam Findings |
0; 0; 0 | — |
| PRIMARY Incidence of Abnormal Serum Chemistries and Hematology |
0; 0; 0 | — |
| PRIMARY Severity of Abnormal Serum Chemistries and Hematology |
0; 0; 0 | — |
| PRIMARY Incidence of Abnormal Vital Signs (Temperature) |
0; 0; 0 | — |
| PRIMARY Severity of Abnormal Vital Signs (Temperature) |
0; 0; 0 | — |
| PRIMARY Incidence of Abnormal Vital Signs (Blood Pressure) |
0; 0; 0 | — |
| PRIMARY Severity of Abnormal Vital Signs (Blood Pressure) |
0; 0; 0 | — |
| PRIMARY Incidence of Abnormal Vital Signs (Heart Rate) |
0; 0; 0 | — |
| PRIMARY Severity of Abnormal Vital Signs (Heart Rate) |
0; 0; 0 | — |
| PRIMARY Incidence and Severity of Adverse Events |
2; 2; 1 | — |
| PRIMARY Incidence of Serious Adverse Events |
0; 0; 0 | — |
| SECONDARY Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmax) |
— | — |
| SECONDARY Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmin) |
— | — |
| SECONDARY Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (CL) |
— | — |
| SECONDARY Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Vss) |
— | — |
| SECONDARY Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (T1/2) |
— | — |
| SECONDARY Assess the Immunogenicity of TRL345 as Measured by Anti-drug Antibodies (ADAs) |
— | — |
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
- 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.
Exclusion Criteria
- Inability to tolerate blood draws or has poor venous access
- Body mass index (BMI) 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)
- Positive test for drugs of abuse, ETOH and nicotine (cotinine) at the Screening Visit
- Positive serum beta-human chorionic gonadotropin test for pregnancy, pregnant, or nursing women
- Unwilling to refrain from donating blood or plasma during the study.
- Use of any new prescription medication or over-the-counter (OTC) product (including natural food supplements, vitamins, herbs) within 14 days prior to dosing
- Receipt of any vaccine or booster within 14 days prior to Day 1 or plan
Data sourced from ClinicalTrials.gov (NCT05408091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.