Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

Zeria Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Iron Deficiency Anemia

Treatments: Drug: Z-213

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170311

Z213-01

Details and patient eligibility

About

The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mild iron deficiency anemia

Exclusion criteria

• Patients with anemia caused by conditions other than iron deficiency
• Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
• Patients with liver, kidney or circulatory system disease
• Patients with a history or present illness that is a malignant tumor or autoimmune disease
• Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
• Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Z-213 100mg

Experimental group

Description:

Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.

Treatment:

Drug: Z-213

Z-213 500mg

Experimental group

Description:

Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.

Treatment:

Drug: Z-213

Z-213 800mg

Experimental group

Description:

Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.

Treatment:

Drug: Z-213

Z-213 1000mg

Experimental group

Description:

Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.

Treatment:

Drug: Z-213