AZD6234 Formulation 1 / AZD6234 Formulation 2 (high concentration) / Healthy Participants · Phase 1 Trial

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

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 registry record for a subcutaneous formulation bioavailability study of AZD6234 in healthy volunteers. No results are posted in this registry entry. The study aims to establish comparative plasma concentration profiles across four formulations but contains no outcome data to evaluate efficacy or safety.

What was studied

Phase 1, Interventional, Randomized, Crossover, Open label, Treatment purpose. Healthy Participants; age from 18 Years; to 55 Years; accepts healthy volunteers. Intervention: Sequence ABCD; Sequence BCAD; Sequence CABD. n = 19. 1 site: United Kingdom.

Key findings

Safety

Study is Phase 1 in healthy volunteers; findings do not establish clinical efficacy or safety in patients.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 bioavailability study in healthy volunteers with surrogate endpoints (plasma concentrations); no results posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Maximum observed plasma concentration (Cmax) (assessed at 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) (assessed at 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) (assessed at Plasma sample collection from pre- dose to 30 days post final dose)

DesignPhase 1, Interventional, Randomized, Crossover, Open label, Treatment purpose

PopulationHealthy Participants; age from 18 Years; to 55 Years; accepts healthy volunteers

Sample size19

InterventionSequence ABCD; Sequence BCAD; Sequence CABD

Setting1 site: United Kingdom

Reported figures

Quoted from the source exactly as published.

Planned enrollment19

PhasePHASE 1

Primary outcome 1Cmax (Maximum observed plasma concentration)

Primary outcome 2AUC0-t (Area under the concentration-time curve from time 0 to last measurable concentration)

Primary outcome 3AUC0-inf (Area under the concentration-time curve from time 0 extrapolated to infinity)

Follow-up duration30 days post final dose

Caveats

This is a registry record only; no results or outcomes are reported.
Study is Phase 1 in healthy volunteers; findings do not establish clinical efficacy or safety in patients.
Randomization, blinding, and comparator details are not described in this record.
Power calculation and statistical analysis plan not stated in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1, cross-over bioavailability design comparing multiple formulations.

Directness

limited

Healthy volunteers; primary endpoints are pharmacokinetic surrogates, not clinical outcomes.

Consistency

insufficient

Single-site study; no comparator data or prior results reported in this record.

Risk of bias

insufficient

Registry record does not describe randomization, blinding, or allocation concealment.

Sample adequacy

limited

19 enrolled in Phase 1 bioavailability study; no power calculation stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07220954). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 19 participants (ACTUAL). Conditions: Healthy Participants. Interventions: DRUG: AZD6234 Formulation 1; DRUG: AZD6234 Formulation 2 (low concentration); DRUG: AZD6234 Formulation 2 (high concentration); DRUG: AZD6234 Formulation 3. Primary outcome measures: Maximum observed plasma concentration (Cmax) , 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) , 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) , Plasma sample collection from pre- dose to 30 days post final dose. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AZD6234 Formulation 1NCT07220954AZD6234 Formulation 2 (high concentration)Healthy ParticipantsAZD6234 Formulation 3AstraZenecaAZD6234 Formulation 2 (low concentration)