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Monoclonal Antibodies

AZD0292 Dose 2 for Healthy Participants

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from dosing (day 1) to end of the study (up to 13 weeks)
Awards & highlights

Study Summary

This trial will test how safe and well-tolerated a new drug, AZD0292, is when given in increasing amounts through a vein to healthy adults. It will also look at how the

Who is the study for?
This trial is for healthy adults who can participate in a study to test the safety of a new drug. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting conditions.Check my eligibility
What is being tested?
The trial is testing AZD0292, given through an IV at increasing doses, against a placebo to see how safe it is and how the body processes it. Participants will be randomly assigned to receive either the drug or placebo.See study design
What are the potential side effects?
Since this is an early-stage trial for AZD0292, potential side effects are being investigated. Common side effects for new drugs may include reactions at the injection site, nausea, headache, or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from dosing (day 1) to end of the study (up to 13 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from dosing (day 1) to end of the study (up to 13 weeks) 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 Participants with Adverse Events
Number of Participants with Adverse Events of Special Interest (AESI)
Secondary outcome measures
Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity)
Maximum Observed Drug Concentration (Cmax)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD0292 Dose 3Experimental Treatment1 Intervention
Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.
Group II: AZD0292 Dose 2Experimental Treatment1 Intervention
Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.
Group III: AZD0292 Dose 1Experimental Treatment1 Intervention
Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo to AZD0292 as IV infusion on Day 1.

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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
4,274 Previous Clinical Trials
288,613,397 Total Patients Enrolled

Frequently Asked Questions

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

Is there an age restriction for potential participants, specifically regarding individuals who are older than 25 years?

"Individuals aged 18 and above but below 60 are eligible for participation in this research."

Answered by AI

Am I eligible to participate in this clinical trial?

"To be considered for this research study, individuals must meet stringent health criteria and fall within the age bracket of 18 to 60 years old. The trial is seeking approximately 24 eligible participants."

Answered by AI

Are individuals currently eligible to apply for participation in this ongoing medical study?

"The active recruitment of participants for this clinical trial, as detailed on clinicaltrials.gov, is currently paused. The study was first listed on 4th September 2024 and last revised on 3rd August 2024. Although enrollment is temporarily halted for this specific trial, there are alternative trials welcoming participants presently."

Answered by AI

What is the primary aim of conducting this clinical investigation?

"The primary focus of this clinical investigation, spanning about Up to 13 weeks, is to determine the incidence of Adverse Events of Special Interest (AESI) among participants. Secondary endpoints include Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast), which involves evaluating the PK profile (AUClast) of AZD0292 after administering ascending IV doses to healthy adults; Number of Participants with Positive Anti-drug Antibodies (ADAs), focusing on ADA responses post-IV administration of escalating AZD0292 doses in healthy adult volunteers; and Area Under Concentration-Time Curve from Time Zero"

Answered by AI

What is the safety profile of AZD0292 Dose 1 for individuals?

"Our team at Power has assessed the safety of AZD0292 Dose 1 to be a level 1 on our scale from 1 to 3. This determination is based on the Phase 1 nature of the trial, indicating scarce supportive data for both safety and efficacy."

Answered by AI
~16 spots leftby Sep 2024