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Dose C IRL201104 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Revolo Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial researches how safe and well-tolerated a drug is and how it moves through the body in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Emergent Adverse Events
Secondary outcome measures
PK parameters of IRL201104 concentration in plasma
Other outcome measures
Incidence of treatment-emergent anti-drug antibody (ADA) responses

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose C IRL201104Experimental Treatment2 Interventions
IRL201104 or placebo IV on days 1 and 7
Group II: Dose B IRL201104Experimental Treatment2 Interventions
IRL201104 or placebo IV on days 1 and 7
Group III: Dose A IRL201104Experimental Treatment2 Interventions
IRL201104 or placebo IV on days 1 and 7
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
IRL201104
2021
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Revolo BiotherapeuticsLead Sponsor
3 Previous Clinical Trials
117 Total Patients Enrolled
Anoshie Ratnayake, MD, MPHStudy DirectorRevolo Biotherapeutics

Media Library

IRL201104 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05921591 — Phase 1
Healthy Subjects Research Study Groups: Dose C IRL201104, Dose B IRL201104, Dose A IRL201104
Healthy Subjects Clinical Trial 2023: IRL201104 Highlights & Side Effects. Trial Name: NCT05921591 — Phase 1
IRL201104 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05921591 — Phase 1

Frequently Asked Questions

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

Is my eligibility in compliance with the criteria to join this research endeavor?

"In order to be accepted into this trial, prospective participants must have no existing medical conditions and fall within the age bracket of 18-55. There are a total of 24 slots available in the study."

Answered by AI

What side effects have been reported from the use of Dose A IRL201104?

"Our team has assessed the safety of Dose A IRL201104 to be a 1. This is due to this being a Phase 1 trial, which indicates that there exists minimal evidence for efficacy and security."

Answered by AI

Does this experiment admit volunteers older than forty?

"The study requires enrollees to be aged between 18 and 55; those below the age of consent or above 65 are excluded from this trial, with there being 55 studies for minors and 368 trials dedicated to seniors."

Answered by AI

How many participants are being recruited for this clinical trial?

"Affirmative. As per the information stored on clinicaltrials.gov, this medical trial is presently seeking qualified candidates for participation. The study was first posted on May 26th 2023 and has been updated most recently June 19th 2023. 24 patients are needed from 1 site of enrolment."

Answered by AI

Is recruitment still ongoing for this experiment?

"This investigation, which first appeared on clinicaltrials.gov on May 26th 2023, is actively enrolling patients according to the most recent update on June 19th 2023."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Revolo Phase I site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long will the trial take? Is it paid?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
2023. "Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05921591.
~13 spots leftby Apr 2025
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