AZD3355 Dose-escalation Study in Healthy Males

A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated Doses in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757419

Enrollment

Registered

2008-09-23

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2010-12-07

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

Conditions

Reflux Disease

Keywords

Safety, tolerability, healthy subjects

Brief summary

The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo (inactive substance). Safety and tolerability variables will be closely monitored throughout the study.

Interventions

DRUGAZD3355

capsules, oral, single or twice daily dose

DRUGPlacebo

To match dosing of AZD3355

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects without concurrent diseases who do not require any medical treatments * Provision of signed informed consent.

Exclusion criteria

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator. * Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator. * History of clinically significant orthostatic reaction or syncope * Clinically important abnormalities related to the heart function

Design outcomes

Primary

Measure	Time frame
Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)	During the study

Secondary

Measure	Time frame
Pharmacokinetic variables	Several occasions during the study days

Countries

Sweden

Outcome results

None listed

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