A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants

February 26, 2025 updated by: AstraZeneca

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, And Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Participants

This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a First-time-in-human (FTiH) trial.

Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention.

The study will comprise:

  1. A Screening Period of maximum 28 days.
  2. A Treatment Period
  3. A Follow-up Period from Day 3 to Day 16
  4. An extended Follow-up Period from Day 17 to Day 61

Participants will be involved in this study for a maximum duration of 13 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All females must have a negative pregnancy test at screening and on admission to the Clinical Unit.
  • Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
  • Have a body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m^2) inclusive and weigh at least 50 kilograms (kg) at screening.

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to screening as well as individuals with a smoking history of tobacco greater than 5 pack years.
  • History of alcohol or drug abuse within the past 2 years that, according to the PI, might affect assessments of safety or ability of participant to comply with all study requirements.
  • Any drug therapy within 7 days prior to Day 1 (except contraceptives, HRT, or a single use of acetaminophen, aspirin, antihistamine, or combination OTC product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, that is, have been taken for at least 30 days prior to enrollment, are not exclusionary.
  • Positive screen for drugs of abuse, alcohol, or cotinine at screening or on admission to the Clinical Unit.
  • Any abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longer) of the study intervention administration in this study. The period of exclusion begins one month after the final dose.
  • Receipt of any vaccine within 7 days prior to study intervention administration or planned receipt within 28 days after study intervention administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZD0292 Dose 1
Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.
Drug: AZD0292
AZD0292 will be administered as single dose via IV infusion.
Experimental: AZD0292 Dose 2
Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.
Drug: AZD0292
AZD0292 will be administered as single dose via IV infusion.
Experimental: AZD0292 Dose 3
Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.
Drug: AZD0292
AZD0292 will be administered as single dose via IV infusion.
Placebo Comparator: Placebo
Participants will receive matching placebo to AZD0292 as IV infusion on Day 1.
Drug: Placebo
Placebo will be administered as IV infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
Up to 13 weeks
Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
Up to 13 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Drug Concentration (Cmax)
Time Frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (Cmax) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
From Dosing (Day 1) to end of the study (up to 13 weeks)
Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
Time Frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (AUClast) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
From Dosing (Day 1) to end of the study (up to 13 weeks)
Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity)
Time Frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (AUCinfinity) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
From Dosing (Day 1) to end of the study (up to 13 weeks)
Number of Participants with Positive Anti-drug Antibodies (ADAs)
Time Frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The ADA responses following IV administration of single ascending doses of AZD0292 to healthy adult participants will be evaluated.
From Dosing (Day 1) to end of the study (up to 13 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7700C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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