A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults

Completed

• Conditions: Asthma; breathing difficulties; 10006436

• Registration Number: NL-OMON37629
• Lead Sponsor: Hoffmann-La Roche

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: 56

Inclusion Criteria

Healthy male or female
age: 18-64 yrs, inclusive
BMI: 18-32 kg/m2, inclusive

Exclusion Criteria

Suffering from: hepatitis B, 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. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study (male)/ more than 1.0 liters of blood in the 10 months preceding the start of the study (female).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>Pharmacokinetics<br /><br>Pharmacodynamics</p><br>

Secondary Outcome Measures

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