NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Rheumatoid Arthritis
Interventions: AZD6912, Placebo
Countries: Canada, United Kingdom
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.
Eligibility overview
Sex: ALL
Age: 18 Years to 50 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Females must have a negative pregnancy test. * Contraceptive use by males and females should be consistent with local regulations. * Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg. * For optional Japanese participants only: * Participants must be of Japanese descent defined as: first generation (born to 2 Japanese parents and 4 Japanese grandparents). * Born in Japan, and not have lived outside Japan for more than 5 years. * Lifestyle, including diet, must not have significantly changed since leaving Japan. Exclusion Criteria: * History of any clinically important disease or disorder. * Current or recurrent disease of clinical significance that could affect clinical assessments or clinical laboratory evaluations. * Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention. * History of congenital or acquired immunodeficiency or complement deficiency or an underlying condition that predisposes to infection. * History of any Neisseria infection, unexplained, recurrent infections, or infection requiring treatment with systemic antibiotics. * Evidence of hepatitis B infection (positive for HBsAg or positive for anti-HBcAb) or hepatitis C viral infection (HCV Abs or hepatitis C RNA positive) or HIV infection (positive for HIV type 1 or type 2 Abs). * Participants testing positive for COVID-19 prior to dosing. * Any cardiac abnormalities. * A CAP activity \< 60% at screening. * Known or suspected history of drug abuse, history of alcohol abuse or smoking.
Locations (2)
- Montreal, Quebec, Canada
- Harrow, United Kingdom