AstraZeneca Initiates First-in-Human Phase I Trial for Novel Investigational Drug D9440C00001

Key Insights

• AstraZeneca has launched a Phase I first-in-human clinical trial for investigational compound D9440C00001, evaluating safety, tolerability, and pharmacokinetics in healthy participants.
• The randomized, single-blind, placebo-controlled study features both single ascending dose and multiple ascending dose components across diverse populations including Japanese and Chinese participants.
• The trial design includes comprehensive assessment periods spanning 6-7 weeks per participant, with systematic dose escalation protocols to establish optimal dosing parameters.

AstraZeneca has commenced a Phase I first-in-human clinical trial for its investigational compound D9440C00001, marking a significant milestone in the drug's development pathway. The randomized, single-blind, placebo-controlled study is designed to evaluate the safety, tolerability, and pharmacokinetics of this novel therapeutic candidate in healthy participants.

Study Design and Structure

The comprehensive trial employs a sequential group design incorporating both single ascending dose (SAD) and multiple ascending dose (MAD) components. Part A of the study encompasses three distinct cohorts: Part A1 enrolling healthy participants, Part A2 focusing on healthy Japanese participants, and Part A3 targeting healthy Chinese participants. Part B consists of two components: Part B1 with healthy participants and Part B2 with healthy Japanese participants.

The study protocol includes a screening period of maximum 28 days for both parts. The treatment period extends from Day -1 to Day 4 in Part A, while Part B features an extended treatment duration from Day -1 to Day 15. Follow-up visits are scheduled for Day 10 ± 3 days for Part A participants and Day 20 ± 3 days for Part B participants.

Participant Timeline and Commitment

Each participant's involvement spans approximately 6 weeks for Part A of the study and 7 weeks for Part B. This timeline encompasses the screening period, treatment phase, and follow-up assessments, ensuring comprehensive safety monitoring and data collection throughout the trial duration.

Clinical Development Significance

This first-in-human study represents a critical step in D9440C00001's clinical development program. The inclusion of diverse ethnic populations, specifically Japanese and Chinese participants, demonstrates AstraZeneca's commitment to understanding potential pharmacokinetic variations across different demographic groups, which is essential for global drug development strategies.

The systematic approach of single and multiple ascending dose evaluations allows researchers to establish dose-response relationships and identify optimal dosing regimens for future clinical phases. The placebo-controlled design ensures robust safety and efficacy assessments while maintaining scientific rigor in this early-stage evaluation.