anemia iron deficiency
Conditions
Interventions
The study will consist of 2 parts (SAD and MAD part):
Part 1 (SAD) will consist of 5 dose groups (of 8 subjects), each group will
stay in the clinical research centre in Groningen for 5 days (4 nigh
the participants will each receive one dose.
In Part 2, per group 8 participants will receive FMX-8 and 2 participants will
receive placebo
the participants will each receive four doses of either FMX-8
or placebo.
Whether you will receive the active drug or placebo will be determined by
chance. Neither the participant nor the investig
Sponsors
FerruMax Pharmaceuticals, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - healthy male subjects - 18-55 yrs, inclusive - BMI: 18.0-30.0 kg/m2, inclusive - non-smoking
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability of FMX-8 and pharmacokinetics of FMX-8 (serum FMX-8 drug concentrations, PK parameters) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameters: TBIC (Total iron-binding capacity), UIBC (Unsaturated iron-binding capacity), TSAT (Transferrin saturation), ferritin, transferrin, reticulocyte count and reticulocyte hemoglobin content | — |
Countries
Netherlands
Outcome results
None listed