Your session is about to expire
← Back to Search
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 belowSelect...
I am a man and will not have sex or will use birth control during the study.
Select...
My blood tests show normal white blood cells, platelets, and hemoglobin levels.
Select...
My kidney function is normal, based on my creatinine levels.
Select...
My liver is functioning well, based on recent blood tests.
Select...
I am 18 years or older and weigh at least 40 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is normal, based on my creatinine levels.My liver is functioning well, based on recent blood tests.I haven't taken immunosuppressants in the last 4 weeks.I haven't taken any experimental drugs or biological treatments in the last month.I do not have dementia or any mental condition that affects my understanding.I do not have serious heart problems.I am a man and will not have sex or will use birth control during the study.I have not had a serious infection in the last 3 months.I have a history of serious health issues.I am not pregnant, planning to become pregnant, or breastfeeding during the study.I have had cancer before, but it meets the trial's exceptions.I have never had PML or any similar nerve diseases.My blood tests show normal white blood cells, platelets, and hemoglobin levels.I have not had major surgery in the last 28 days.I am 18 years or older and weigh at least 40 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Hutrukin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger