Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05098080 | Hutrukin to Analyze Safety and PK in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Apr 10, 2023 | Apr 5, 2024 | Jul 23, 2024 | 1 | United States |
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...