AZD2373 subcutaneous injection for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Brooklyn, MD
Healthy Subjects (HS)
AZD2373 subcutaneous injection - Drug
Eligibility
18 - 65
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and well tolerated in healthy male participants of sub-Saharan West African ancestry. The study will also look at how the drug is processed by the body. The injection of AZD2373 is used to treat Healthy Subjects, and has been approved by the FDA for a different condition. The treatment is free of charge.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Days -35 to -1 (Screening period)

Days -35 to -1 (Screening period)
APOL1 allele status
Week 16
AUCinf
AUCt
AUCτ
Cmax
t1/2
tmax
Week 21
Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or injection site reactions
Percent change in plasma APOL1 protein from baseline

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

5 Treatment Groups

Cohort 4 (optional)
1 of 5
Cohort 1
1 of 5
Cohort 3
1 of 5
Cohort 2
1 of 5
Cohort 5 (optional)
1 of 5
Experimental Treatment

40 Total Participants · 5 Treatment Groups

Primary Treatment: AZD2373 subcutaneous injection · Has Placebo Group · Phase 1

Cohort 4 (optional)Experimental Group · 2 Interventions: Placebo, AZD2373 subcutaneous injection · Intervention Types: Drug, Drug
Cohort 1Experimental Group · 2 Interventions: Placebo, AZD2373 subcutaneous injection · Intervention Types: Drug, Drug
Cohort 3Experimental Group · 2 Interventions: Placebo, AZD2373 subcutaneous injection · Intervention Types: Drug, Drug
Cohort 2Experimental Group · 2 Interventions: Placebo, AZD2373 subcutaneous injection · Intervention Types: Drug, Drug
Cohort 5 (optional)Experimental Group · 2 Interventions: Placebo, AZD2373 subcutaneous injection · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days -35 to -1 (screening period)
Closest Location: Research Site · Brooklyn, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
1900First Recorded Clinical Trial
311 TrialsResearching Healthy Subjects (HS)
2958 CompletedClinical Trials

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,939 Previous Clinical Trials
91,873,169 Total Patients Enrolled
271 Trials studying Healthy Subjects (HS)
35,932 Patients Enrolled for Healthy Subjects (HS)
ParexelIndustry Sponsor
265 Previous Clinical Trials
94,941 Total Patients Enrolled
27 Trials studying Healthy Subjects (HS)
1,319 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18 - 65 · Male Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have provided written informed consent prior to any study specific procedures.
You have provided a written and signed informed consent and completed the mandatory genotyping in the pre-screening study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.