CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled / 16 target
Drug / intervention
TRL345, a human monoclonal antibodydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05408091
NCT05408091Phase 1CompletedUpdate Overdue (0.5/mo)Completion was 18mo ago
CompareCT.gov

A Phase 1, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL345 in Healthy Volunteers

Trellis Bioscience LLC·interventional·Posted Jun 7, 2022·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating TRL345, a human monoclonal antibody for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJun 7, 2022
Enrollment StartSep 14, 2023
Primary CompletionDec 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.1 years ago

Arms & Interventions

Dose Level 1 - 1 mg/kgexperimental

Randomized 6:2 (TRL345:placebo) via IV infusion

Drug: TRL345, a human monoclonal antibody
Dose Level 2 - 10 mg/kgexperimental

Randomized 6:2 (TRL345:placebo) via IV infusion

Drug: TRL345, a human monoclonal antibody

Interventions

TRL345, a human monoclonal antibodydrug

Anti-Human Cytomegalovirus (HCMV) IgG1κ Human Monoclonal Antibody