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Hutrukin · 1 trial · 1 indication
Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v5.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.
| Arm | Type | Description |
|---|---|---|
| Hutrukin | ACTIVE_COMPARATOR | At least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin. |
| Placebo | PLACEBO_COMPARATOR | At least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo. |
| Name | Type | Description |
|---|---|---|
| Hutrukin | BIOLOGICAL | 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. |
| Placebo | BIOLOGICAL | Placebo control for Hutrukin IV push. |
Inclusion Criteria: 1. Age: ≥18 and weight ≥40 kg. 2. Adequate bone marrow function defined as: * absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L) * platelet count \> 150,000/mm3 * hemoglobin of ≥ 10 g/dL 3. Adequate renal function, defined by serum creatini...
Hutrukin is an investigational monoclonal antibody developed by XBiotech Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease indications for Hutrukin have not been publicly disclosed, and the program remains in early clinical development.
Hutrukin is being developed by XBiotech Inc., which trades on the Nasdaq under the ticker symbol XBIT. XBiotech is the sponsor of the clinical program evaluating Hutrukin. The company is a biopharmaceutical developer focused on monoclonal antibody therapeutics.
Hutrukin is in Phase 1 clinical development. Its only recorded trial, NCT05098080, was a Phase 1 study that has been completed. Hutrukin is investigational and has not been approved by the FDA for any indication.
Hutrukin has been evaluated in one clinical trial, NCT05098080, titled "Hutrukin to Analyze Safety and PK in Healthy Volunteers." The Phase 1 study enrolled 24 healthy adult volunteers in the United States, was placebo controlled and randomized, and has been completed.
The Phase 1 trial NCT05098080 evaluated the safety and pharmacokinetics of Hutrukin in healthy volunteers. It enrolled 24 participants aged 18 years and older of all sexes in the United States. The study was randomized and placebo controlled, and it has been completed.