A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects

NCT05794672 | Terminated Phase 1

• 2 other identifiers: D2912C000022022-000426-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.

Conditions

Healthy Subjects (Indication: Asthma)

Keywords

Heterogenous respiratory disease; Pulmonary inflammation; Healthy subjects; Japanese subjects; Interleukin 4 receptor alpha antagonist

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse events

  The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.

  Up to Follow-up [Part A: 60 days, Part B: 67 days)

• Collection of blood samples for the measurement of safety immunobiomarkers

  The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.

  Part A: Screening (Day -28) to Day 3; Part B: Screening (Day -28 to -2) to Follow-up ([Day 37 ± 2)]

Secondary Outcomes (5)

• Maximum observed serum (peak) drug concentration [Cmax]

  Part A: Day 1 to Day 3, Part B: Day 1 to Day 9

• Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast)

  Part A: Day 1 to Day 3, Part B: Day 1 to Day 9

• Area under serum concentration time curve from zero to infinity (AUCinf)

  Day 1

• Presence of elarekibep Antidrug Antibody (ADA)

  Part A: Day 1; Part B: Day 1, Day 14 to Follow-up/ETV ([Day 37 ± 2)

• Standardised taste questionnaires

  Part A: Day 1, Part B: Day 1

Study Arms (2)

Part A

EXPERIMENTAL

Part A1: Each subject in three of the single inhaled dose cohorts will receive a single inhaled dose A, B, or C elarekibep and placebo in the fourth cohort. Part A2: Each subject will receive a single Intravenous (IV) dose D elarekibep in one cohort.

Drug: Elarekibep; Drug: Placebo

Part B

EXPERIMENTAL

Each subject will receive multiple inhaled doses C elarekibep or placebo twice daily (BID) for 6 days in the first cohort and a single inhaled dose on Day 7 in the second cohort.

Drug: Elarekibep; Drug: Placebo

Interventions

Elarekibep DRUG

Subjects will receive single or multiple inhaled doses A, B or C, or single IV dose D of elarekibep.

Also known as: AZD1402

Part A; Part B

Placebo DRUG

Subjects will receive single or multiple inhaled doses A, B or C.

Part A; Part B

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be aged 20 to 55 years.
• Subject must have a Body Mass Index (BMI) between 18 and 35 kg/m2 and weigh a minimum of 48 kg.
• First generation subjects who were born in Japan and who have both parents and grandparents of Japanese descent.
• All females must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) to the Clinical Unit and must not be lactating or planning to become pregnant.
• Subjects who are non-smokers or ex-smokers who have smoked no more than twice in the 3 months preceding the first dose of study drug.
• Must be able to demonstrate proper inhalation technique using the monodose Dry Powder Inhaler (DPI) device.
• Able to perform acceptable pulmonary function testing for Forced Expiratory Volume in one second (FEV1) according to American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.

You may not qualify if:

• History or clinical manifestations of any clinically significant medical disorder which may either put the subject at risk because of participation in the study, influence the results, or affect the subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease.
• Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of Day 1 or planned in-patient surgery or hospitalization during the study period.
• Diagnosis of Sjögren's syndrome.
• Any laboratory values with deviations from the study's laboratory parameters.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• Known or suspected history of drug abuse in the last 5 years.
• Known or suspected history of alcohol abuse or excessive intake of alcohol in the last 2 years.
• Positive screen for drugs of abuse, alcohol or cotinine at the Screening Visit.
• History of anaphylaxis following any biologic therapy or vaccine and known history of allergy or reaction to any component of the Investigational Medicinal Product (IMP) formulation.
• Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss \> 450 mL during the 3 months prior to the Screening Visit.
• Excessive intake of caffeine containing drinks or food.
• Participation in more than 4 clinical studies with IMPs in the last year.
• Involvement of subjects who have a significant history of recurrent or ongoing dry eye syndrome of any cause that may be chronic or acute and that may affect the interpretation of safety data associated with the potential for ADAs targeted to elarekibep.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 3, 2023
• Study Start: April 11, 2023
• Primary Completion: July 8, 2023
• Study Completion: July 8, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

GB (1)