What side effects are associated with this type of intervention?

In pharmacokinetics studies of treatments similar to HutrukinTM, common side effects often include mild to moderate local injection site reactions such as erythema, pain, or bruising. Serious adverse effects are uncommon but can include hypersensitivity reactions like rash, pruritus, and urticaria. Rarely, severe allergic reactions such as nummular eczema, severe urticaria, and hypersensitivity vasculitis have been reported. Neurocognitive symptoms and muscle toxicity are generally not significant concerns in these treatments.

What prior FDA approvals exist?

The FDA has approved several drugs that focus on pharmacokinetics, particularly in the context of safety and efficacy assessments. For example, avatrombopag, a thrombopoietin receptor agonist, has undergone extensive pharmacokinetic and pharmacodynamic studies to ensure its safety and optimal dosing in patients with chronic liver disease and immune thrombocytopenia. These studies are similar to the safety and pharmacokinetics assessments being conducted for HutrukinTM. Other related drugs include recombinant factor VIII products for hemophilia, which have also been evaluated for their pharmacokinetic profiles to ensure prolonged activity and safety in patients.

What other types of research exist?

Promising alternatives to HutrukinTM for pharmacokinetics patients include Alectinib, Crizotinib, Entrectinib, Ceritinib, and Lorlatinib. These drugs have shown efficacy and safety in various clinical trials and are being considered for their pharmacokinetic profiles in treating conditions like non-small cell lung cancer.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

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.

0 / 11Eligibility criteria met

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.