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Virus Therapy

Hutrukin for Pharmacokinetics

Phase 1
Waitlist Available
Led By Neha Reshamwala, MD
Research Sponsored by XBiotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants must agree to abstain from sexual intercourse or use reliable contraception
Adequate bone marrow function: absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3, platelet count > 150,000/mm3, hemoglobin of ≥ 10 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is to test the safety and how well a new drug, called HutrukinTM, works in healthy people. There will be three groups of people, each taking a different dose of the drug.

Who is the study for?
Healthy adults over 18 years old and weighing at least 40 kg can join this trial. They must have good bone marrow, kidney, and liver function. Men should use contraception or be vasectomized; women must not be pregnant and use effective birth control if of childbearing potential. People with recent serious heart issues, mental incapacity, certain medication histories, severe allergies to monoclonal antibodies, significant infections or diseases in the last few months cannot participate.Check my eligibility
What is being tested?
The study is testing Hutrukin's safety and how it's processed by the body (pharmacokinetics) in healthy volunteers. Participants will receive one of three different doses: 1,000 mg, 3,000 mg or 5,000 mg. It's an early-stage trial (Phase I), where everyone knows which treatment they're getting (open label).See study design
What are the potential side effects?
Since this is a Phase I trial primarily focused on safety and dosage levels for Hutrukin in humans for the first time after preclinical studies on animals or tissues have been completed successfully without detailed side effects available yet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man and will not have sex or will use birth control during the study.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My kidney function is normal, based on my creatinine levels.
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My liver is functioning well, based on recent blood tests.
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I am 18 years or older and weigh at least 40 kg.

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
Number of subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level.
Secondary outcome measures
Half-life
Maximum plasma concentration of test article
Plasma concentration at various time points including terminal concentration
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HutrukinActive Control1 Intervention
At least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin.
Group II: PlaceboPlacebo Group1 Intervention
At least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

XBiotech, Inc.Lead Sponsor
5 Previous Clinical Trials
505 Total Patients Enrolled
1 Trials studying Pharmacokinetics
24 Patients Enrolled for Pharmacokinetics
Neha Reshamwala, MDPrincipal InvestigatorBioBehavioral Research of Austin
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Pharmacokinetics
24 Patients Enrolled for Pharmacokinetics

Media Library

HutrukinTM (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05098080 — Phase 1
Pharmacokinetics Research Study Groups: Hutrukin, Placebo
Pharmacokinetics Clinical Trial 2023: HutrukinTM Highlights & Side Effects. Trial Name: NCT05098080 — Phase 1
HutrukinTM (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098080 — Phase 1

Frequently Asked Questions

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

Has HutrukinTM attained regulatory sanction from the FDA?

"As HutrukinTM is currently in Phase 1 of the clinical trial process, its safety has been preliminarily assessed and it was assigned a score of 1. As such, there are only limited details on how efficacious this particular drug may be."

Answered by AI

Are there still opportunities for recruitment into this research project?

"Per clinicaltrials.gov, this medical trial is not currently enrolling patients - the first post was on August 2nd 2022 and the most recent update being May 5th 2022. Although subject recruitment has ceased for this particular study, there are 39 alternative trials actively seeking participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hutrukin to Analyze Safety and PK in Healthy Volunteers
2023. "Hutrukin to Analyze Safety and PK in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098080.
~12 spots leftby Apr 2025
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