A double-blind, randomized, placebo-controlled, combined single and multiple ascending dose study to investigate the safety, tolerability and pharmacokinetic profile of AB928 in healthy volunteers.
Completed
- Conditions
- Cancer.Kanker
- Registration Number
- NL-OMON46373
- Lead Sponsor
- Arcus Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Inclusion Criteria
Healthy volunteers
Age 18 - 55 years, inclusive
BMI 19 - 30 kilograms/meter2
Non-smokers or ex-smokers who ceased smoking > 3 months prior to screening visit
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 assess the safety and tolerability of AB928 after single and multiple oral<br /><br>doses.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the potential pharmacodynamic (PD) effects of AB928<br /><br>To characterize the pharmacokinetic (PK) profile of AB928 after single and<br /><br>multiple oral doses<br /><br>To investigate the effect of food on the PK of AB928<br /><br>To investigate the bioequivalence (BE) of 2 formulations of AB928<br /><br>To determine if any QTc prolongation occurs with AB928</p><br>