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Study to Evaluate Safety and Activity of Inhaled TRL1068 in Healthy Volunteers

NCT07644195 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-06-12

No results posted yet for this study

Summary

This study in healthy volunteers will provide a basis for evaluation of inhaled TRL1068 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data.

Conditions

  • Healthy Volunteer

Interventions

DRUG

TRL1068, a human monoclonal antibody

The IP will be in a solution for inhalation at a nominal concentration of 20 mg/mL. The IP will be reconstituted with a formulation buffer to 10 mg/mL/PS20 0.055% and dosed at a fixed dose of 60 mg per dose (volume of 6 mL) to full completion. Placebo will be normal saline. This study will use a marketed nebulizer device, the Aerogen Solo™, which is designed to generate an aerosol to achieve effective levels of TRL1068 in distal airways.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Trellis Bioscience LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644195 on ClinicalTrials.gov