Hutrukin for Pharmacokinetics

Overseen By Haritha Pallapotu, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: XBiotech, Inc.

Must not be taking: Biologicals, Immunosuppressants

Disqualifiers: Cardiovascular disease, Dementia, Infection, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Neha Reshamwala, MD

Principal Investigator

BioBehavioral Research of Austin

Eligibility Criteria

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

My kidney function is normal, based on my creatinine levels.

My liver is functioning well, based on recent blood tests.

For female subjects of childbearing potential WOCBP, a negative pregnancy test at screening and agreement to reliable contraception

Exclusion Criteria

I haven't taken immunosuppressants in the last 4 weeks.

I haven't taken any experimental drugs or biological treatments in the last month.

History of immunodeficiency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 10 days

Treatment

Participants receive one intravenous push of Hutrukin or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood chemistry, hematology, and Hutrukin serum/plasma concentrations

28 days

Multiple visits (in-person)

Treatment Details

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).

Participant Groups

Group I: Hutrukin Active Control 1 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: Placebo Placebo Group 1 Intervention

At least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo.

Who Is Running the Clinical Trial?

XBiotech, Inc.

Lead Sponsor

Trials

8

Recruited

740+