A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Inhaled TRL1068 in Healthy Volunteers
Trellis Bioscience LLC
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.
Description
This is a Phase 1, double-blind study to assess the safety and PK of inhaled TRL1068. Healthy subjects aged 18-65, inclusive, will be screened. Subjects who meet all inclusion and no exclusion criteria will be enrolled into the study, assigned to a dose group (DG), and randomized to receive IP. The single dose (SD) study (Study Part A) will enroll one dose group (DG) of 7 healthy participants (5 active and 2 placebo), with each participant receiving a single inhaled dose of TRL1068 or matching placebo \[IP\]. This DG will include a sentinel group of two participants (1 active and 1 placebo) w…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. 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 2. Normal spirometry at Screening, defined as FEV1 ≥ 80% 3. Willing and able to provide written informed consent 4. Availability for the entire duration of the study, and willingness to adhere to protocol requirements 5. 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…
Interventions
- DrugTRL1068, 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.
Location
- CelerionLincoln, Nebraska