Unknown

AZD2373 subcutaneous injection for Healthy Subjects

Research Site, Brooklyn, MD
AZD2373 subcutaneous injection +1 morePhase 1Waitlist AvailableResearch Sponsored by AstraZeneca

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days -35 to -1 (screening period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and days -35 to -1 (screening period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
APOL1 allele status
AUCinf
AUCt
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5 (optional)Experimental Treatment2 Interventions
Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects).
Group II: Cohort 4 (optional)Experimental Treatment2 Interventions
Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects).
Group III: Cohort 3Experimental Treatment2 Interventions
Three times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects).
Group IV: Cohort 2Experimental Treatment2 Interventions
Once weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects).
Group V: Cohort 1Experimental Treatment2 Interventions
Once weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2373 subcutaneous injection
2022
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670

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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
4,136 Previous Clinical Trials
336,503,665 Total Patients Enrolled
ParexelIndustry Sponsor
288 Previous Clinical Trials
93,452 Total Patients Enrolled

Frequently Asked Questions

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

Who meets the criteria to participate in this medical experiment?

"The trial is seeking around 40 participants who are between 18 and 55 years old, with healthy subjects (hs)."

Answered by AI

Does this investigation include geriatric participants?

"This medical trial is available to patients aged 18-55 who meet the required criteria."

Answered by AI

Are new participants being enrolled in this experiment currently?

"Indeed, clinicaltrials.gov confirms that this medical study is actively recruiting volunteers and was first posted on April 4th 2022. The most recent update of the experiment took place November 30th 2022 and 40 individuals are needed to be recruited from a single site."

Answered by AI

What is the upper capacity for people participating in this medical experiment?

"Affirmative. Clinicaltrials.gov indicates that the specified trial is currently enrolling individuals, which commenced on April 4th 2022 and was last updated on November 30th of the same year. 40 patients are being accepted from a single medical centre."

Answered by AI

Is the subcutaneous injection of AZD2373 considered secure for patients?

"Taking into account the limited efficacy and safety data available, our team at Power has assigned a score of 1 to AZD2373 subcutaneous injection."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry
2022. "A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05351047.
~10 spots leftby Oct 2024
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