Single Ascending Dose Study (SAD) iv Formulation

A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688831

Acronym

2006-006253-27

Enrollment

Registered

2008-06-03

Start date

2008-01-31

Completion date

2008-05-31

Last updated

2010-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD1305, SAD, safety, pharmcokinetics, Safety and tolerability

Brief summary

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body

Interventions

DRUGAZD1305

Solution for iv infusion , single dose

DRUGPlacebo

NaCl solution for iv infusion, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * BIM 19-30 kg/m2

Exclusion criteria

* Potassium outside normal reference values * ECG findings outside normal range

Design outcomes

Primary

Measure	Time frame
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight	During the study

Secondary

Measure	Time frame
Pharmacokinetic variables	During all dosing visits

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026