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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 a monoclonal antibody being studied for pharmacokinetics. It is currently in Phase 1 clinical development as an investigational drug. The completed trial evaluated its safety and pharmacokinetic profile in healthy volunteers, with no approved indications at this time.
Hutrukin is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its pharmacokinetic properties, meaning how it is absorbed, distributed, metabolized, and excreted in the body, rather than for a particular disease target.
Hutrukin is being developed by XBiotech Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XBIT. The company is conducting clinical research on this monoclonal antibody candidate.
Hutrukin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
Hutrukin has one completed Phase 1 clinical trial, identified as NCT05098080, titled "Hutrukin to Analyze Safety and PK in Healthy Volunteers." The trial enrolled 24 healthy adult participants in the United States and was placebo-controlled, though not double-blinded.
No alternative names for Hutrukin have been disclosed. It is identified solely by its investigational name and is being developed as a distinct monoclonal antibody candidate by XBiotech Inc.