An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)
Completed
- Conditions
- PNH10038158
- Registration Number
- NL-OMON43007
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
healthy male volunteers
21-55 yrs, inclusive
BMI: 18-30 kg/m2, inclusive
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>- Evaluate the safety and tolerability of single doses of RO7112689 in HVs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Characterize the pharmacodynamic (PD) effects of a single-dose of RO7112689<br /><br>on complement activity and other related biomarkers.<br /><br>- Describe the single-dose pharmacokinetic (PK) profile of RO7112689.<br /><br>- Explore the PK/PD relationship of single-ascending doses of RO7112689 on<br /><br>complement activity and other related biomarkers.<br /><br>- Evaluate the immunogenicity of RO7112689 in healthy volunteers.<br /><br>- Assess the bioavailability of SC administration of RO7112689.<br /><br>- Assess ethnic sensitivities across Japanese and non-Japanese healthy<br /><br>volunteers.</p><br>