Assessing the safety and effects of AZD4144 in healthy individuals

A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants

This study is testing a new drug called AZD4144 in healthy people to see if it's safe and how it works in the body, including how it interacts with other common medications.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 2 sites (Glendale, California and 1 other locations)
• Trial ID: NCT06491550 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 in healthy participants. It consists of three parts: Part A and Part B, which are single-blind, placebo-controlled assessments of AZD4144, and Part C, which investigates potential drug-drug interactions between AZD4144 and oral medications rosuvastatin and furosemide. Participants will undergo a screening period followed by a residential dosing period, with follow-up visits to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-55 with a BMI between 18 and 32 kg/m2.

Not a fit: Patients with pre-existing health conditions or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and interaction profiles of AZD4144, potentially leading to improved treatment options.

How similar studies have performed: Other studies have shown success in assessing pharmacokinetics and drug interactions, making this approach a continuation of established methodologies.

Eligibility criteria

Inclusion Criteria:

* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
* Females of non-childbearing potential must be confirmed at the Screening Visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
* For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese, 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 all grandparents are Chinese and not lived outside of China for more than 10 years.

Exclusion Criteria:

* History of any clinically important disease or disorder 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.
* Clinically significant serious active and chronic infections.
* Any history or evidence of TB (active or latent).
* Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
* Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.
* Any abnormal laboratory values at the Screening Visit or on Admission to the Clinical Unit.
* Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).
* Any clinically important abnormalities in ECG.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Known hypersensitivity to furosemide and rosuvastatin (for Part C only)
* History of alcohol abuse or excessive intake of alcohol or current smokers or those who have smoked or used nicotine products.
* Use of drugs with enzyme inducing properties or of any prescribed or nonprescribed medication or of systemic hormonal contraceptives.
* Clinical signs and symptoms consistent with COVID-19.

Where this trial is running

Glendale, California and 1 other locations

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

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Pharmacokinetic; Pharmacodynamic; Drug-drug interaction; Single ascending dose; Multiple ascending dose