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Anti-tumor antibiotic

AZD5004 for Healthy Subjects

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
* Must have suitable veins for cannulation or repeated venipuncture.
* Female(s) of Childbearing Potential must use adequate contraception (oral contraceptives are not permitted).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 2) to days 49, 91 and 106
Awards & highlights

Summary

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants.

Who is the study for?
This trial is for healthy individuals who want to participate in a study assessing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.
What is being tested?
The trial is testing AZD5004, given as multiple oral doses, against a placebo (a substance with no active drug). It aims to understand how safe AZD5004 is and how it's processed by the body when taken more than once.
What are the potential side effects?
Since this is an early-stage trial for AZD5004 in healthy volunteers, potential side effects are being investigated. Commonly, such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 2) to days 49, 91 and 106
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 2) to days 49, 91 and 106 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary study objectives
Absolute change from Baseline in BMI (kg/m^2)
Absolute change from Baseline in body weight (kg)
Amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD5004Experimental Treatment1 Intervention
Participants will receive AZD5004 orally.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching Placebo orally.

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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
4,331 Previous Clinical Trials
288,640,070 Total Patients Enrolled
~10 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
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