A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects - HM10660A first-in-man study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35906

Enrollment

Registered

2011-03-15

Start date

2011-03-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

C Hepatitis B viral liver inflamation

Interventions

Active substance: HM10660A, Pegasys (PEG interferon alfa) or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Gender: male Age: 18 * 45 years, inclusive BMI: 18.0 * 28.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1.5 liter of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
safety and tolerability	—

Secondary

Measure	Time frame
pharmacokinetics pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)