NCT05098080

Hutrukin to Analyze Safety and PK in Healthy Volunteers

2021-PT054: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin Via Intravenous Administration in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: XBiotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 (1,000 mg, 3,000 mg and 5,000 mg).

Detailed description

Study Title: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin via Intravenous Administration in Healthy Subjects Sponsor: XBiotech USA, Inc. Study Chair: Neha Reshamwala, MD Number of Planned Subjects: 24 healthy subjects with 8 subjects in each of the dose cohorts of HutrukinTM. Approximate Duration: Approximately 38 days which includes a screening period of up to 10 days followed by one intravenous push of Hutrukin and then evaluation over 28 days. Blood will be sampled at various time points for blood chemistry, hematological assessment and Hutrukin serum/plasma concentrations. Safety and tolerability will be evaluated.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
BIOLOGICAL	Hutrukin	Hutrukin that binds the human cytokine IL-1α with high affinity and is an effective blocker of IL-1α biological activity. Hutrukin is a True Human™ therapeutic antibody. That is, the antibody was generated by a natural human immune response and was cloned directly from a human peripheral B lymphocyte. No in vitro affinity maturation or modifications have been made to improve its natural binding affinity. A true human antibody should be effectively non-immunogenic in humans and thus exhibit optimal activity and pharmacokinetics indistinguishable from native IgG1 immunoglobulin.
BIOLOGICAL	Placebo	Placebo control for Hutrukin IV push.

Timeline

• Start date: 2023-04-10
• Primary completion: 2023-10-24
• Completion: 2024-04-05
• First posted: 2021-10-28
• Last updated: 2024-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study