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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants

NCT06122714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-12-13

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.

Conditions

  • Healthy Participants

Interventions

DRUG

AZD4144 Part A

Part A: Participants will be administered a single oral dose on Day 1.

DRUG

AZD4144 Part B

Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.

DRUG

Placebo Part A

Part A: Participants will be administered a single oral dose of matching placebo on Day 1.

DRUG

Placebo Part B

Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2024-12-04
Completion
2024-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122714 on ClinicalTrials.gov