Investigating the safety and effects of AZD8965 in healthy participants

A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants

This study is testing a new drug called AZD8965 in healthy people to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 163 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Glendale, California)
• Trial ID: NCT06502379 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of AZD8965 through single and multiple ascending doses in healthy participants, including specific cohorts of Japanese and Chinese individuals. It consists of four parts: single ascending dose, multiple ascending dose, Japanese and Chinese single ascending dose, and an assessment of the food effect on pharmacokinetics. Participants will undergo a 28-day screening period followed by a residential phase where they will be monitored closely after receiving the study intervention. The study aims to gather critical data on how AZD8965 behaves in the body under different conditions.

Who should consider this trial

Good fit: Ideal candidates are healthy male and female participants, including those of Japanese and Chinese descent, who meet specific health criteria.

Not a fit: Patients with pre-existing health conditions or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and dosing of AZD8965, potentially leading to new treatment options for lung diseases.

How similar studies have performed: While this study is focused on a specific drug and population, similar studies assessing pharmacokinetics in healthy participants have shown success in the past.

Eligibility criteria

Inclusion Criteria:

* Healthy male and female participants (including Japanese and Chinese participants) with suitable veins for cannulation or repeated venipuncture.
* All females of childbearing potential must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) to the Clinical Unit.
* All females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception with low user dependency and their non-sterilized male partners must use a condom, to avoid pregnancy from the time of first administration of study intervention until 20 days after the last dose of study intervention. Females must not use hormonal contraceptives or hormone replacement therapy during the study.
* Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:

  1. Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and without an alternative medical cause and the follicle stimulating hormone (FSH) level is in the postmenopausal range.
  2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not acceptable.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 20 days after the last dose of study intervention.
* Have a body mass index (BMI) between 18 and 30 kilogram (kg)/square meter (m2) inclusive and weigh at least 45 kg.

Part 3A and Part 3B (Japanese Participants)

* Healthy Japanese participants are eligible based on meeting all of the following:

  1. Born in Japan
  2. Have 2 Japanese biological parents and 4 Japanese grandparents.
  3. Did not live outside Japan for more than 10 years at the time of Screening. Part 3A and Part 3B (Chinese Participants)
* Healthy Chinese participants. Participants of Chinese ancestry are eligible based on meeting all of the following:

  1. Born in mainland China, Hong Kong, Macau, or Taiwan
  2. Have 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.
  3. Did not live outside China for more than 10 years at the time of Screening.

Exclusion Criteria:

* History of any clinically important disease or disorder which may either put the participant at risk or influence the results or the participant's ability to participate in the study.
* Chronic or ongoing gastrointestinal, respiratory, hepatic, renal disease, pancreatic disease, diabetes mellitus, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Chronic or ongoing neurological disorder, any clinically important past or ongoing psychiatric disorder which may confound assessment of the potential neurologic effects of this product.
* Participants with a history of hypertension or cardiovascular disease.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Participant with chronic infections (e.g., urinary tract infection) or who are at increased risk of infection (e.g., surgery, trauma, severe dental disease, or significant infection).
* Participants with a known or suspected defect in the function of the urea cycle, or with family history of a urea cycle disorder in one or more biological relative.
* Any abnormal laboratory values and vital signs.
* Ongoing acquired or inherited immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) or common variable immunodeficiency, or the participant is taking immune replacement therapy.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8965.

Where this trial is running

Glendale, California

• Research Site — Glendale, California, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Idiopathic Pulmonary Fibrosis; Lung disease; Pharmacokinetics; Food Effect