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

NCT07220954 | Not Yet Recruiting Phase 1

• 1 other identifier: D8750C00008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Relative Bioavailability; Pharmacokinetics; Obesity; Overweight

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

  Plasma sample collection from pre- dose to 30 days post final dose

• Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t)

  Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

  Plasma sample collection from pre- dose to 30 days post final dose

• Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)

  Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

  Plasma sample collection from pre- dose to 30 days post final dose

Secondary Outcomes (5)

• Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests

  Through study duration, approximately 19 weeks

• Time of maximum observed plasma concentration (tmax)

  Plasma sample collection from pre- dose to 30 days post final dose

• Terminal elimination half-life (t1/2)

  Plasma sample collection from pre- dose to 30 days post final dose

• Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)

  Plasma sample collection from pre- dose to 30 days post final dose

• Volume of distribution based on the terminal phase calculated using AUC0-inf after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F)

  Plasma sample collection from pre- dose to 30 days post final dose

Study Arms (3)

Sequence ABCD

EXPERIMENTAL

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)

Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3

Sequence BCAD

EXPERIMENTAL

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)

Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3

Sequence CABD

EXPERIMENTAL

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)

Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3

Interventions

AZD6234 Formulation 1 DRUG

AZD6234 Formulation 1 will be administered as a single SC injection

Also known as: AZD6234

Sequence ABCD; Sequence BCAD; Sequence CABD

AZD6234 Formulation 2 (low concentration) DRUG

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

Also known as: AZD6234

Sequence ABCD; Sequence BCAD; Sequence CABD

AZD6234 Formulation 2 (high concentration) DRUG

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

Also known as: AZD6234

Sequence ABCD; Sequence BCAD; Sequence CABD

AZD6234 Formulation 3 DRUG

AZD6234 Formulation 3 will be administered as a single SC injection

Also known as: AZD6234

Sequence ABCD; Sequence BCAD; Sequence CABD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quotient Sciences: collaborator

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to 1 of 3 treatment sequences

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 24, 2025
• Study Start: November 10, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

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 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)