A Phase I, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

D7130C00001

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

2023-11-15

2025-06-27

2025-06-27

Recruiting

Early phase I

64

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.

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2024-03-15