AstraZeneca is conducting two separate early-stage clinical trials to evaluate the safety, tolerability, and pharmacokinetic properties of experimental compounds AZD2389 and AZD5004, representing the company's ongoing commitment to expanding its drug development pipeline.
AZD2389 Dose-Escalation Study
The AZD2389 trial follows a comprehensive dose-escalation design across 11 distinct cohorts, systematically evaluating both single and multiple ascending doses in healthy volunteers. The study structure includes three main parts: Part A1 (Cohorts 1-6), Part A2 (Cohorts 7-9), and Part A3 (Cohort 10), with an additional multiple ascending dose component in Part B1 (Cohort 11).
Each cohort typically enrolls 8 participants, with 6 receiving active treatment and 2 receiving matching placebo, except for Cohort 6 which includes only active treatment participants. This randomized, placebo-controlled approach allows researchers to establish safety profiles while minimizing bias in early-phase testing.
The oral administration route for AZD2389 provides practical advantages for future clinical development, as participants receive the compound as either single ascending doses or multiple ascending doses depending on their assigned cohort. The systematic dose escalation across multiple cohorts enables researchers to identify the maximum tolerated dose and optimal dosing regimen for potential future studies.
AZD5004 Development Program
The AZD5004 study employs a dual-part design addressing both safety evaluation and formulation optimization. Part A represents a placebo-controlled assessment of safety, efficacy, tolerability, and pharmacokinetics during repeated dosing over 106 days, preceded by a screening period of up to 28 days and followed by a 14-day follow-up visit.
Part B focuses on bioavailability comparison through a two-way crossover study examining two oral tablet strengths of Formulation 1. This component specifically aims to expand product knowledge regarding plasma exposure levels between different tablet strengths, providing crucial data to guide Phase 3 drug product development.
The crossover design divides participants into two groups with alternating treatment sequences. Group 1 receives Treatment 1 followed by Treatment 2, while Group 2 follows the reverse sequence. Each treatment period spans 7 days, with a final follow-up visit occurring approximately 6 days after the last dose administration.
Clinical Development Strategy
Both studies reflect AstraZeneca's systematic approach to early-stage drug development, employing rigorous methodologies to establish safety profiles and optimize dosing strategies. The AZD2389 program's extensive cohort structure allows for comprehensive dose-response evaluation, while the AZD5004 study's dual-part design addresses both safety assessment and formulation optimization in a single protocol.
The inclusion of placebo controls across both programs ensures robust safety evaluation, while the systematic dose escalation and bioavailability assessments provide essential data for advancing these compounds through clinical development. These studies represent critical steps in determining whether either compound warrants progression to later-phase trials.
