A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers.

A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers. - ALX 0651 SAD and open-label extension in healthy male

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35929

Enrollment

Registered

2011-05-30

Start date

2011-06-28

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

stamcel mobilisatie beenmerg bloedvormende stamcellen

Interventions

ALX-0651 as bolus injection for first dose level, rest by iv

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male volunteer - Age between 18-55 years - BMI between 19-29 kg/m2 - Only non-smokers

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B or 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 90 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 pharmacokinetics pharmacodynamics biologically effective dose (BED) and/or maximum tolerated dose (MTD) potential immunogenicity	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)