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Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: profile 0-48 hours after dose, day 16; profile 0-72 hours after dose

Summary

This trial tests a new drug called AZD5055 in healthy people to see if it is safe and how the body handles it. Participants will receive different doses of the drug over a period of time. The study will help determine the best dose and understand any potential side effects.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: profile 0-48 hours after dose, day 16; profile 0-72 hours after dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: profile 0-48 hours after dose, day 16; profile 0-72 hours after dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Number of participants with adverse events (AEs)
Part 2: Number of participants with AEs
Secondary study objectives
Part 1: Accumulation ratio (Rac)
Part 1: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Part 1: Apparent volume of distribution following extravascular administration based on terminal phase (Vz/F)
+28 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 (multiple ascending doses [MAD])Experimental Treatment2 Interventions
Healthy participants will be randomized to repeated dosing with AZD5055 or placebo
Group II: Part 1 (single ascending doses [SAD])Experimental Treatment2 Interventions
Healthy participants will be randomized to a single dose of AZD5055 or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
AZD5055
2023
Completed Phase 1
~110

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,123,530 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
86 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~15 spots leftby Dec 2025
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