Hutrukin for Pharmacokinetics
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how a new treatment, HutrukinTM, behaves in the body and to assess its safety. Researchers will test different doses of HutrukinTM and compare them to a placebo (a substance with no active drug) in healthy volunteers. They seek participants who are generally in good health and have not experienced certain health issues, such as uncontrolled heart problems or recent infections. If these criteria are met, and there is an interest in advancing medical research, this trial might be suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken any biologicals or investigational agents in the last 4 weeks, or immunosuppressant agents in the last 4 weeks.
Is there any evidence suggesting that HutrukinTM is likely to be safe for humans?
Research has shown that Hutrukin has been tested in healthy volunteers to assess its safety. In one study with 24 participants, researchers administered the treatment in three different doses to evaluate tolerance.
The study monitored for any side effects or reactions. As one of the first human tests, researchers are still learning about Hutrukin's safety. Early studies like this typically focus on safety, so side effects receive close attention.
If a treatment is approved for use in other conditions, it often has a known safety profile. However, since Hutrukin remains under investigation, participants should be aware that not all potential side effects may be known yet.12345Why do researchers think this study treatment might be promising?
HutrukinTM is unique because it utilizes a novel active ingredient that could offer a new approach to managing its targeted condition. Unlike current treatments that typically rely on established pathways, Hutrukin works by potentially providing a more direct and efficient mechanism, possibly leading to quicker results. Researchers are excited about Hutrukin due to its promising pharmacokinetic profile across multiple dose levels, which could translate to improved patient outcomes and fewer side effects compared to existing options.
What evidence suggests that HutrukinTM could be effective?
Research is exploring Hutrukin as a potential treatment to reduce inflammation in stroke patients. Studies have suggested it might decrease damage when blood flow returns to the brain after a stroke. Although detailed information from human studies remains limited, Hutrukin's mechanism indicates it could help manage stroke-related injuries. In this trial, participants will receive varying doses of Hutrukin or a placebo to assess its safety and how the body processes the drug. This initial safety testing is crucial for determining its potential effectiveness for stroke treatment in the future.16789
Who Is on the Research Team?
Neha Reshamwala, MD
Principal Investigator
BioBehavioral Research of Austin
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one intravenous push of Hutrukin or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood chemistry, hematology, and Hutrukin serum/plasma concentrations
What Are the Treatments Tested in This Trial?
Interventions
- HutrukinTM
Trial Overview
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).
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
At least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin.
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 Clinic Near You
Who Is Running the Clinical Trial?
XBiotech, Inc.
Lead Sponsor
Citations
Hutrukin to Analyze Safety and PK in Healthy Volunteers
The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts.
2.
investors.xbiotech.com
investors.xbiotech.com/news-releases/news-release-details/xbiotech-announces-enrollment-completion-phase-i-clinical-trialRelease Details - Investor Relations - XBiotech
The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Sequential dose ...
3.
xbiotech.com
xbiotech.com/news/another-milestone-achieved-in-phase-i-clinical-trial-for-hutrukin-tm-stroke-drugMilestone for Hutrukin™ Stroke Treatement Candidate
XBiotech is conducting a Phase I study to evaluate the safety and pharmacokinetics of its stroke therapy candidate, Hutrukin, in healthy volunteers.
XBiotech enrols first patient in ischemic stroke therapy trial
Hutrukin therapy is known to reduce inflammatory injury associated with reperfusion, an advancement in the management of stroke patients. A ...
Hutrukin for Pharmacokinetics · Info for Participants
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.
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researchgate.net
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