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

NCT06311760 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: D7700C00001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants Study

Keywords

Monoclonal antibody

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  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)

  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 Outcomes (4)

• Maximum Observed Drug Concentration (Cmax)

  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)

  From Dosing (Day 1) to end of the study (up to 13 weeks)

• Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity)

  From Dosing (Day 1) to end of the study (up to 13 weeks)

• Number of Participants with Positive Anti-drug Antibodies (ADAs)

  From Dosing (Day 1) to end of the study (up to 13 weeks)

Study Arms (4)

AZD0292 Dose 1

EXPERIMENTAL

Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.

Drug: AZD0292

AZD0292 Dose 2

EXPERIMENTAL

Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.

Drug: AZD0292

AZD0292 Dose 3

EXPERIMENTAL

Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.

Drug: AZD0292

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to AZD0292 as IV infusion on Day 1.

Drug: Placebo

Interventions

AZD0292 DRUG

AZD0292 will be administered as single dose via IV infusion.

AZD0292 Dose 1; AZD0292 Dose 2; AZD0292 Dose 3

Placebo DRUG

Placebo will be administered as IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 any vaccine within 7 days prior to study intervention administration or planned receipt within 28 days after study intervention administration.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 9, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)