Phase I, single-centre, randomised, placebo-controlled, double-blinded study, with single ascending dose and multiple dose at maximum tolerated dose, evaluating the safety, tolerability and pharmacokinetics of ALX-0171, administered by pulmonary inhalation, in healthy male volunteers

Phase I, single-centre, randomised, placebo-controlled, double-blinded study, with single ascending dose and multiple dose at maximum tolerated dose, evaluating the safety, tolerability and pharmacokinetics of ALX-0171, administered by pulmonary inhalation, in healthy male volunteers - ALX-0171 Phase I study in healthy male volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37342

Enrollment

100

Registered

2011-10-27

Start date

2011-11-16

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

respiratory syncytial virus infection virus that infect the airways

Interventions

Study Medication Active substance: ALX-0171 Activity: Inhibition of the fusion (F) protein of hRSV Indication: treatment of human respiratory syncytial virus (hRSV) infection Strength: 50 mg/ml Dosag

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male volunteers - Age between 18 - 55 years - BMI between 18.0 - 30.0 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 of 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
Pharmacokinetics: plasma ALX-0171 concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, pulmonary function	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)