A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

Launched by ASTRAZENECA · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AZD6912 to see how safe it is, how well the body absorbs it, and how it affects the body when given as a single injection under the skin. The trial is open to healthy participants between the ages of 18 and 62, and it aims to gather important information that could help in developing treatments for rheumatoid arthritis.

To be eligible for this study, participants must be healthy, with a body mass index (BMI) between 18 and 30, and weigh at least 50 kg. Women must have a negative pregnancy test, and both men and women should use birth control. There are some health conditions that would exclude someone from participating, such as recent serious illnesses, infections, or heart problems. If someone joins the study, they can expect to receive the medication and be monitored closely to ensure their safety throughout the trial.

Gender

ALL

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.