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AZD5055 for Idiopathic Pulmonary Fibrosis

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
Awards & highlights

Study Summary

This trial is testing a new drug in two parts. The first part is a single ascending dose study, where participants receive increasing doses of the drug until the maximum tolerated dose is reached. The second part is a multiple ascending dose study, where participants receive the drug at different dose levels to see how well it is tolerated.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of participants with adverse events (AEs)
Part 2: Number of participants with AEs
Secondary outcome measures
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
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,842 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
86 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to take part in this research endeavor?

"This clinical trial seeks 90 participants with usual interstitial pneumonia, aged between 18 and 55. Eligible applicants must fulfill the following criteria: healthy males/females of non-childbearing age (Part 1 - 18 to 55 years old; Part 2 - Males from18 to55, Females from 18 to 49), have a body mass index within the range of 18 and 30 kg/m2, weigh no less than 50kgs, female subjects must take a negative pregnancy test prior joining in addition male subjects & their partners should use reliable contraception methods throughout the study period plus an additional 17 days after taking part."

Answered by AI

Is this research endeavor actively recruiting new participants?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking volunteers after being posted on November 18th 2021 and last updated December 1st 2022. Aspiring participants will need to come from one site, with the trial needing 90 enrollees in total."

Answered by AI

What impact is this trial expected to have on the healthcare industry?

"This clinical trial will evaluate the number of participants with adverse effects over a 53-day period. Secondary outcomes include data points such as cumulative amount of unchanged drug excreted into urine, area under plasma concentration time curve from zero to infinity and apparent volume of distribution following extravascular administration based on terminal phase."

Answered by AI

What potential risks exist for individuals taking AZD5055?

"Evaluators from Power have assigned AZD5055 a score of 1 based on the limited data available for its safety and efficacy profile, as this is only in Phase 1 trials."

Answered by AI

How many individuals have been included in the research thus far?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this investigation is actively recruiting participants, having been first posted on November 18th 2021 and most recently amended on December 1st 2022. In total, 90 individuals are required for enrolment at a single medical site."

Answered by AI

Does the age of a patient affect their eligibility for this research study?

"Eligible participants for this trial must have an age between 18 to 55. For individuals below or above those ages, there are 7 and 91 studies respectively that may accommodate their needs."

Answered by AI
~18 spots leftby Apr 2025