TerminatedPhase 1ACTRN12606000459527

A Phase I Open-Label, Single Dose, Dose Escalation Study of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)

A Phase I Open-Label, Single Dose, Dose Escalation Study to investigate the safety and tolerability of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)

Sponsor

KaloBios Pharmaceuticals Inc

Enrollment

27 participants

Start Date

Feb 15, 2007

Study Type

Interventional

Conditions

Idiopathic Thrombocytopenia Purpura (ITP)

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: A Phase I Open-Label, Single Dose, Dose Escalation Study of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP). It is open to Both males and females, aged 18 and older. To take part, you generally need: < 50 x 109/L for patients receiving a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1). There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will receive a single intravenous infusion of KB002. The first 6 patients will be assigned to Dose Level 1 (0.2 mg/kg). If there are no dose limiting toxicities (DLTs) during the first 7 da

Patients will receive a single intravenous infusion of KB002. The first 6 patients will be assigned to Dose Level 1 (0.2 mg/kg). If there are no dose limiting toxicities (DLTs) during the first 7 days after their infusion, the next 6 patients will be assigned to Dose level 2 (1.0 mg/kg). If there are no DLTs during the first 7 days after their infusion, the next 6 patients will be assigned to the final Dose Level 3 (5.0 mg/kg). If a DLT occurs in any dose level then an additional 3 patients will be assigned to that dose level. Dose escalation can only occur if there are no further DLTs in the additional 3 patients.

Locations(1)

Australia

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ACTRN12606000459527