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Unknown
AZD4076 for Healthy Male Subjects
Phase 1
Waitlist Available
Led By Ronald Goldwater, MDCM, M.Sc, CPI
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until 16 weeks postdose, up to 5 months
Awards & highlights
Study Summary
This trialtests a drug to see if it's safe, tolerated and how it affects the body in healthy males at different doses.
Who is the study for?
Healthy male participants aged 18-50, with a BMI of 18-30 kg/m2 and weighing between 50-100 kg. They must have good veins for blood draws, provide consent, not smoke or use nicotine in the past three months, avoid certain medications before the trial, and not donate plasma or significant amounts of blood recently.Check my eligibility
What is being tested?
The study is testing AZD4076 tetracosasodium's safety and how it's processed by the body at different doses compared to a placebo. It's a first-in-human study involving healthy men who will receive single increasing doses to assess tolerability.See study design
What are the potential side effects?
Since this is an initial test of AZD4076 in humans (first-in-human), specific side effects are unknown but may include typical drug reactions like nausea, headaches, dizziness or allergic responses. Participants will be closely monitored for any adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18 and 30, and I weigh between 50kg and 100kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening until 16 weeks postdose, up to 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until 16 weeks postdose, up to 5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The safety and tolerability of AZD4076 by assessing clinical chemistry
The safety and tolerability of AZD4076 by assessing hematology
The safety and tolerability of AZD4076 by assessing the injection site
+10 moreSecondary outcome measures
AUC assessed for AZD4076 metabolites from the plasma data
Brain Diseases, Metabolic
AUC(0-last) assessed forAZD4076 metabolites from the plasma data
+29 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 6Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Group II: Cohort 5Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Group III: Cohort 4Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Group IV: Cohort 3Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Group V: Cohort 2Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Group VI: Cohort 1Experimental Treatment2 Interventions
Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4076
2016
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670
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
288,593,862 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
3,404 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Ronald Goldwater, MDCM, M.Sc, CPIPrincipal InvestigatorPAREXEL Early Phase Clinical Unit Baltimore
2 Previous Clinical Trials
143 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medication that affects enzyme activity.I haven't donated blood or plasma in the last month.I have signed and agreed to participate in genetic research.I have minor health issues that could affect study results.I can communicate clearly with my doctor.I have had a bone marrow transplant.I have not taken any experimental drugs recently.I have not received a whole blood transfusion in the last 4 months.I have liver, kidney disease, or a condition affecting drug metabolism.I don't have any serious health issues that could affect the study.I might have Gilbert's syndrome according to my liver tests.I am a healthy man aged 18-50 with good veins for needle procedures.My BMI is between 18 and 30, and I weigh between 50kg and 100kg.I haven't taken any medication, prescribed or not, in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 3
- Group 5: Cohort 5
- Group 6: Cohort 6
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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