AZD3974 safety and pharmacokinetics in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, randomized, single-blind, placebo-controlled protocol has two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Part A (SAD) enrolls several cohorts of general healthy participants and dedicated cohorts of Japanese and Chinese descent, including a cohort with a food-effect evaluation. Part B (MAD) enrolls multiple cohorts of healthy participants and a Japanese cohort to evaluate repeat dosing safety and pharmacokinetics. Each participant completes screening (up to 28 days), a dosing session, and a 7-day follow-up after the last dose with intensive safety and PK sampling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
* All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
* For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
* For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.

Exclusion Criteria:

* History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
* Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiography at Screening and/or admission to the Clinical Unit .
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* Positive screen for drugs of abuse, or alcohol, or cotinine.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Participants who have previously received AZD3974.

Where it's running

• Research Site
  Glendale, California, United States Recruiting
• Research Site
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How age affects germinal center responses after flu and rabies vaccines

  Researchers will test how the immune system responds to flu and rabies vaccines in younger adults (18–40) and older adults (65+).

  Recruiting Phase 4 Washington University School of Medicine · St Louis, Missouri · NCT07914673

• Magnetic field maps with NV sensors for non-invasive heart measurements

  This study tests whether diamond-based NV magnetometers can non-invasively detect and map the heart's magnetic field in healthy adults.

  Recruiting Robert Bosch GmbH · Renningen · NCT07908173

• Methylation analyses using home-based self-sampling in women with and without gynecological disease

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation markers that distinguish people with gynecological (pre-)cancers from cancer-free controls.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902388

• Omega-3 status in healthy adults: comparing different fish-oil and algae-oil products

  This study tests whether various fish-oil and algae-oil products can raise the Omega-3 Index in healthy adults who don’t eat much fatty fish.

  Recruiting Nordic Naturals · London, Ontario · NCT07900425

• A safe, carefully dosed test of TBD11 in healthy adults

  This phase 1 study tests TBD11 in healthy adults to see if it is safe and tolerable and to understand how it behaves in the body, including how it interacts with other medicines.

  Recruiting Phase 1 Gates Medical Research Institute · Bloemfontein · NCT07883226

• Fosmanogepix in healthy adults: how it may interact with other drugs and heart rhythm

  This study tests whether fosmanogepix (and its active form manogepix) changes how other medicines work in healthy adults.

  Recruiting Phase 1 Basilea Pharmaceutica · Groningen, Netherlands · NCT07881224

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.