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

NCT06115967

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