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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Trellis Bioscience LLC
Study ID
NCT07644195
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • TRL1068, a human monoclonal antibody — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Dose
    Randomized 5:2 (TRL1068:placebo) via inhalation. Administered once on Day 1.
  • Experimental: Multiple Dose
    Randomized 5:2 (TRL1068:placebo) via inhalation. Administered four times, on Days 1, 3, 5, and 7.

Primary Outcome Measure

Incidence of abnormal physical exam findings [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionLincolnNebraska68502-

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By research site
Celerion· Lincoln, NE

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