A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234

NCT ID: NCT07220954

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2026-03-24

Brief Summary

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This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234.

This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.

Detailed Description

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This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234.

This study will take place at one site in Nottingham, United Kingdom.

It plans to enrol 21 healthy men and women aged 18-55 years.

Each volunteer will take part in 4 treatment periods and receive different formulations of AZD6234, by injection under the skin into the abdomen (stomach). In each period they'll be given a single dose without food. They'll stay in the clinic for 6 nights on 4 occasions, attend up to 10 outpatient visits, and take up to 19 weeks to finish the study.

Blood and urine samples will be collected to: measure the amount of AZD6234 and its breakdown products, do safety tests and assess the effect of the test medicine on the immune system response.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomized to 1 of 3 treatment sequences
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence ABCD

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment A in Period 1, Treatment B in Period 2, Treatment C in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Group Type EXPERIMENTAL

AZD6234 Formulation 1

Intervention Type DRUG

AZD6234 Formulation 1 will be administered as a single SC injection

AZD6234 Formulation 2 (low concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

AZD6234 Formulation 2 (high concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

AZD6234 Formulation 3

Intervention Type DRUG

AZD6234 Formulation 3 will be administered as a single SC injection

Sequence BCAD

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment B in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Group Type EXPERIMENTAL

AZD6234 Formulation 1

Intervention Type DRUG

AZD6234 Formulation 1 will be administered as a single SC injection

AZD6234 Formulation 2 (low concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

AZD6234 Formulation 2 (high concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

AZD6234 Formulation 3

Intervention Type DRUG

AZD6234 Formulation 3 will be administered as a single SC injection

Sequence CABD

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment C in Period 1, Treatment A in Period 2, Treatment B in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Group Type EXPERIMENTAL

AZD6234 Formulation 1

Intervention Type DRUG

AZD6234 Formulation 1 will be administered as a single SC injection

AZD6234 Formulation 2 (low concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

AZD6234 Formulation 2 (high concentration)

Intervention Type DRUG

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

AZD6234 Formulation 3

Intervention Type DRUG

AZD6234 Formulation 3 will be administered as a single SC injection

Interventions

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AZD6234 Formulation 1

AZD6234 Formulation 1 will be administered as a single SC injection

Intervention Type DRUG

AZD6234 Formulation 2 (low concentration)

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

Intervention Type DRUG

AZD6234 Formulation 2 (high concentration)

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

Intervention Type DRUG

AZD6234 Formulation 3

AZD6234 Formulation 3 will be administered as a single SC injection

Intervention Type DRUG

Other Intervention Names

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AZD6234 AZD6234 AZD6234 AZD6234

Eligibility Criteria

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Inclusion Criteria

* Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
* BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg

Exclusion Criteria

* History of any clinically important disease or disorder
* History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or gastrointestinal disorder including a history of pancreatitis or gall stones
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the planned first dosing day
* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
* Any clinically significant abnormal findings in vital signs
* Any clinically significant abnormalities on 12-lead ECG
* HbA1c ≥6.5% (≥48 mmol/mol)
* Evidence of renal impairment
* Females who are pregnant or lactating.
* Any participant who has received an amylin analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer)
* Participants who report to have previously received AZD6234.
* Use of any prescribed or non-prescribed medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quotient Sciences

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Ruddington, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D8750C00008

Identifier Type: -

Identifier Source: org_study_id

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