Assessing the safety and effects of AZD6912 in healthy participants

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

This study is testing a new drug called AZD6912 to see how safe it is and how it affects healthy people compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 2 sites (Montréal, Quebec and 1 other locations)
• Trial ID: NCT06115967 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD6912, administered subcutaneously to healthy participants. Participants will be randomly assigned to receive either AZD6912 or a placebo in a First-In-Human design. The study includes a screening period, a treatment period with close monitoring, and follow-up visits to assess the return of complement activity to normal levels. The total duration of the study is approximately 25 months, with individual participation lasting about 38 weeks.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 with a BMI between 18 and 30 kg/m2.

Not a fit: Patients with significant underlying health conditions or recent illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with rheumatoid arthritis.

How similar studies have performed: Other studies have shown promise with similar pharmacological approaches, but this specific intervention is novel.

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.

Where this trial is running

Montréal, Quebec and 1 other locations

• Research Site — Montréal, Quebec, Canada (Recruiting)
• Research Site — Harrow, United Kingdom (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Rheumatoid Arthritis; Complement factor B; Small interfering ribonucleic acid; CFB messenger ribonucleic acid