A randomized, adaptive, investigator/subject blind, single ascending dose, placebo-controlled phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered RO7049665 in healthy volunteers.

Completed

• Conditions: Auto immune diseases; 10003816

• Registration Number: NL-OMON47456
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

healthy male subjects
18 - 45 years, inclusive
BMI 18.0 - 30.0 kg/m2
non smokers

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters 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>To evaluate the safety and tolerability of single-ascending doses of<br /><br>subcutaneous (SC) injections of RO7049665 in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the single dose pharmacokinetics of RO7049665 in healthy<br /><br>volunteers.</p><br>