TRL1068 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhaled treatment called TRL1068 to assess its safety and how the body processes it. Researchers are using this treatment in humans for the first time and aim to gather crucial safety and tolerability data. The study involves healthy volunteers receiving either a single or multiple doses of TRL1068 or a placebo. Individuals who are generally healthy and can breathe easily may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that TRL1068 is likely to be safe for humans?
An earlier study tested TRL1068 on people with long-term bacterial joint infections. The results showed that participants generally tolerated the treatment well. Most side effects were mild, such as a sore throat or slight cough, and these symptoms resolved on their own.
Since this marks the first human trial of TRL1068, the study places significant emphasis on monitoring safety issues. The goal is to identify any common or serious side effects. Current information suggests that TRL1068 is safe to use, with no major safety problems reported.12345Why do researchers think this study treatment might be promising?
TRL1068 is unique because it is administered via inhalation, offering a potentially faster and more direct delivery method compared to traditional oral or injectable treatments. Researchers are excited about TRL1068 because it targets the condition with a novel mechanism of action, which may lead to quicker symptom relief. Additionally, the multiple-dose regimen allows for consistent and sustained treatment over a short period, which could enhance its effectiveness compared to existing options.
What evidence suggests that TRL1068 might be an effective treatment?
TRL1068 is a new treatment under investigation for safety and efficacy when inhaled. In this trial, participants will receive either a single dose or multiple doses of TRL1068 through randomization. Lab studies have shown that TRL1068 targets specific pathways in the body that may aid in alleviating breathing problems. These studies suggest it could reduce inflammation, often associated with lung issues. Although human trials have provided limited information so far, the mechanism of TRL1068 offers researchers hope for its potential to address lung inflammation. Further research is necessary to understand its effects in people.
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to take part in a research study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Dose Treatment
Participants receive a single inhaled dose of TRL1068 or placebo
Multiple Dose Treatment
Participants receive inhaled doses of TRL1068 or placebo every other day for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TRL1068
Trial Overview
The study is testing the safety and how the body processes an inhaled drug called TRL1068, which is a human monoclonal antibody. This is the first time this drug will be given to people.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Randomized 5:2 (TRL1068:placebo) via inhalation. Administered once on Day 1.
Randomized 5:2 (TRL1068:placebo) via inhalation. Administered four times, on Days 1, 3, 5, and 7.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trellis Bioscience LLC
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Citations
Study to Evaluate Safety and Activity of Inhaled TRL1068 in ...
This study in healthy volunteers will provide a basis for evaluation of inhaled TRL1068 as a first in human study, specifically, important ...
2.
ctv.veeva.com
ctv.veeva.com/study/study-to-evaluate-safety-and-activity-of-inhaled-trl1068-in-healthy-volunteersStudy to Evaluate Safety and Activity of Inhaled TRL1068 in ...
This study in healthy volunteers will provide a basis for evaluation of inhaled TRL1068 as a first in human study, specifically, important ...
Trellis - News
With its proprietary CellSpot™ platform to identify monoclonal antibodies from the blood of healthy human donors, Trellis identified TRL 1068 as a potential ...
trellis bioscience, inc.
Here, we propose to conduct a Phase 1 safety trial in healthy adult volunteers ... By the time that TRL1068 has been tested for safety in humans, the data ...
concept activity of a biofilm-disrupting human monoclon
This first-in-human study of TRL1068 was conducted in volunteers who had a chronic bacterial periprosthetic joint infection of the knee or hip.
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