A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234
NCT ID: NCT07220954
Last Updated: 2025-10-24
Study Results
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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NOT_YET_RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2025-11-10
2026-03-24
Brief Summary
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This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
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)
AZD6234 Formulation 1
AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3
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)
AZD6234 Formulation 1
AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3
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)
AZD6234 Formulation 1
AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3
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
AZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3
AZD6234 Formulation 3 will be administered as a single SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Quotient Sciences
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Ruddington, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D8750C00008
Identifier Type: -
Identifier Source: org_study_id
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