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

Completed

• Conditions: respiratory syncytial virus infection; 10047438; virus that infect the airways; 10024970

• Registration Number: NL-OMON37342
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- Healthy male volunteers
- Age between 18 - 55 years
- BMI between 18.0 - 30.0 kg/m2
- Only non-smokers

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: plasma ALX-0171 concentrations, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, pulmonary function</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>