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AZD5148 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy participants with suitable veins for cannulation or repeated venipuncture at the time of consent
All women must have a negative serum pregnancy test at the Screening Visit
Must not have
Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture
History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in previous 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose), day 29, day 91, day 181 and day 361
Awards & highlights

Summary

"This trial aims to test how safe and well-tolerated a new drug, AZD5148, is when given as a single dose either through an IV drip or a muscle injection in healthy volunteers

Who is the study for?
Healthy adults with good veins for blood draws can join. Women must not be pregnant, and if they can have children, they need to use birth control. People of Chinese descent must meet specific ancestry criteria. You can't join if you've had a serious illness or surgery recently, any history of cancer (except certain skin/cervical cancers), immune problems including HIV, drug/alcohol abuse, bleeding disorders, are detained or under legal supervision.
What is being tested?
The trial is testing AZD5148's safety and how the body processes it after one dose given by IV or IM injection in healthy people. Some will get AZD5148; others will get a placebo (no active drug) to compare results.
What are the potential side effects?
Since this is an early-stage study on healthy volunteers to assess safety and tolerability, potential side effects aren't listed but may include typical reactions at the injection site like pain or swelling, allergic reactions, or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have veins suitable for repeated needle insertions.
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I have taken a pregnancy test and it was negative.
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I am a woman who can have children and my pregnancy test was negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of significant bleeding or bruising from injections or blood draws.
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I have had no cancers in the past 5 years, except for skin or cervical cancer that was treated locally.
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I have not used strong immune-weakening drugs or have HIV.
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I haven't donated blood or lost more than 500 mL of blood in the last 3 months.
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I have not received any blood products or immunoglobulin in the last 6 months and do not expect to receive any during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose), day 29, day 91, day 181 and day 361
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose), day 29, day 91, day 181 and day 361 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).
Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Secondary study objectives
Apparent total body clearance (IM administration only) (CL/F)
Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F)
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)
+10 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 5: AZD5148 (dose 4) IVExperimental Treatment2 Interventions
Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus
Group II: Cohort 4b: AZD5148 (dose 3) IVExperimental Treatment2 Interventions
Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus
Group III: Cohort 4a: AZD5148 (dose 3) IVExperimental Treatment2 Interventions
Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus
Group IV: Cohort 3: AZD5148 (dose 2) IVExperimental Treatment2 Interventions
Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus
Group V: Cohort 2b: AZD5148 (dose 2) IMExperimental Treatment2 Interventions
Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection
Group VI: Cohort 2a: AZD5148 (dose 2) IMExperimental Treatment2 Interventions
Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection
Group VII: Cohort 1: AZD5148 (dose 1) IMExperimental Treatment2 Interventions
Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
4,352 Previous Clinical Trials
288,646,725 Total Patients Enrolled
~48 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
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