A phase I double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ascending single doses of ANF-Rho in comparison to standard of care-Neulasta® in healthy volunteers

A phase I double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ascending single doses of ANF-Rho in comparison to standard of care-Neulasta® in healthy volunteers - ANF-Rho Phase I study in HV and comparability with Neulasta

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41975

Enrollment

Registered

2014-09-01

Start date

2014-09-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

shortage of white blood cells

Interventions

On Day 1 you will receive ANF Rho, Neulasta® or placebo after breakfast in the morning through an injection under the skin of the abdomen. In the highest dose group (50 µg/kg) of ANF Rho, the dose w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male/female subjects 18-55 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive

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 12 weeks from the start of the study. In case of donating more than 1.5 liters of blood (for men) or 1.0 liter of blood (for women) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To determine the plasma pharmacokinetic profiles of ANF-Rho at ascending single dose in healthy volunteers in comparison to Neulasta® (SOC).	—

Secondary

Measure	Time frame
Pharmacodynamic: -To determine the effect on absolute neutrophil counts (ANC) and CD 34+ cells in increasing doses of ANF-Rho in healthy volunteers in comparison to placebo and Neulasta®. To assess the immunogenicity potential of ANF-Rho by measuring antibodies and neutralizing antibodies to ANF-Rho following a single subcutaneous dose. To assess the occurrence and severity on bone pain in increasing doses of ANF-Rho in healthy volunteers in comparison to placebo and Neulasta®.	—

Measure

Time frame

Pharmacodynamic: -To determine the effect on absolute neutrophil counts (ANC) and CD 34+ cells in increasing doses of ANF-Rho in healthy volunteers in comparison to placebo and Neulasta®. To assess the immunogenicity potential of ANF-Rho by measuring antibodies and neutralizing antibodies to ANF-Rho following a single subcutaneous dose. To assess the occurrence and severity on bone pain in increasing doses of ANF-Rho in healthy volunteers in comparison to placebo and Neulasta®.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)