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TRL345 Antibody for Healthy Volunteers
Study Summary
This trial will evaluate the safety, tolerability, and effectiveness of TRL345 in healthy volunteers. It will help decide the best dose for a clinical study in transplant patients.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
Are there still open slots available for prospective participants of this clinical trial?
"Affirmative, the information found on clinicaltrials.gov indicates that this trial is still open to participants and has been since September 14th 2023. The experiment requires a total of 16 individuals at 1 site."
What is the current total of participants for this experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this trial is presently enrolling individuals. This research project was initially published on September 14th 2023 and has been recently updated on the same date. It requires 16 subjects at a single centre for completion of its objectives."
Does this experimental procedure accept people aged 35 or older?
"This trial has an age restriction that applicants must meet before being eligible, with the minimum age of admittance set at 18 and the upper limit capped at 65."
What aims is this clinical investigation attempting to achieve?
"Trellis Bioscience LLC, the clinical trial's sponsor, has stated that their primary measure of success over 11 weeks is assessing abnormal heart rate readings. Additionally, secondary outcomes such as Cmax and Cmin values determined by ELISA tests will be used to characterize a single intravenous infusion of TRL345."
Has the Federal Drug Administration authorized the 10 mg/kg dosage strength of Level 2?
"Due to the lack of clinical data on safety and efficacy, Dose Level 2 - 10 mg/kg received a score of 1."
Who has been approved to participate in this trial?
"This clinical trial is recruiting for 16 healthy individuals between the age of 18-65. Candidates must fulfill the following prerequisites: Be a nonpregnant, nonbreastfeeding adult representative of general population; Give written informed consent and availability throughout study duration; Pass health assessments done at Screening Visit as judged by PI or delegatee; For WOCBP practice highly effective contraception from 28 days before screening to Day 76 - this may include abstinence, monogamous relationship with vasectomized partner, hormonal methods etc.; Men also must refrain from donating sperm during that time period."
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