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Monoclonal Antibody

TRL345 Antibody for Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by Trellis Bioscience LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights

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.

Who is the study for?
Healthy adults aged 18-65 who can commit to the study schedule and follow contraception guidelines. Excluded are those with certain blood, heart, liver, kidney issues, recent vaccinations or drug trials participation, diabetes, infections, substance abuse history or taking new medications.Check my eligibility
What is being tested?
TRL345 is being tested for safety and how it's processed in the body (pharmacokinetics). This first-in-human trial will help determine proper dosing for future studies in transplant patients by also looking at its antiviral activity outside of the body.See study design
What are the potential side effects?
Since this is a first-in-human study of TRL345, specific side effects are not yet known. However, as with any monoclonal antibody treatment potential side effects could include allergic reactions or infusion-related responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Adverse Events
Incidence of Serious Adverse Events
Incidence of abnormal physical exam findings
+9 more
Secondary outcome measures
Assess the immunogenicity of TRL345 as measured by anti-drug antibodies (ADAs)
Characterize the pharmacokinetics (PK) of a single IV infusion of TRL345 overall and by DG (CL)
Characterize the pharmacokinetics (PK) of a single IV infusion of TRL345 overall and by DG (Cmax)
+3 more
Other outcome measures
Exploration of possible off-target binding - IL-1alpha
Exploration of possible off-target binding - LDH
Exploration of possible off-target binding - gastrointestinal and CNS AEs
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Level 2 - 10 mg/kgExperimental Treatment1 Intervention
Randomized 6:2 (TRL345:placebo) via IV infusion
Group II: Dose Level 1 - 1 mg/kgExperimental Treatment1 Intervention
Randomized 6:2 (TRL345:placebo) via IV infusion

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Trellis Bioscience LLCLead Sponsor
2 Previous Clinical Trials
27 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,221 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Nov 2024