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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
Must not have
Dementia or altered mental status affecting informed consent
Uncontrolled or significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

This trial tests a new drug called HutrukinTM in healthy volunteers to see if it is safe and to understand how it behaves in the body. The study involves giving the drug through an injection and observing the volunteers for several weeks.

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.
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).
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have dementia or any mental condition that affects my understanding.
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I do not have serious heart problems.
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I have not had a serious infection in the last 3 months.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
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I have never had PML or any similar nerve diseases.
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I have not had major surgery in the last 28 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pharmacokinetics involves the study of how drugs are absorbed, distributed, metabolized, and excreted in the body. Treatments like HutrukinTM, which are assessed for safety and pharmacokinetics, often focus on optimizing these processes to ensure maximum efficacy and minimal toxicity. The mechanisms of action for such treatments typically include enhancing drug absorption, improving distribution to target tissues, and ensuring efficient metabolism and excretion. This is crucial for pharmacokinetics patients as it helps in achieving the desired therapeutic effect while minimizing adverse effects, thereby improving overall treatment outcomes.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

XBiotech, Inc.Lead Sponsor
6 Previous Clinical Trials
572 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
~10 spots leftby Sep 2025
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