This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030224

Enrollment

Registered

2009-12-11

Start date

2009-11-30

Completion date

2010-03-31

Last updated

2012-07-27

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

Conditions

Healthy

Keywords

Healthy volunteer, First time in human

Brief summary

The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

Interventions

DRUGAZD9742

Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee

DRUGPlacebo to match AZD9742

Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

23 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures. * Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG. * Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product * History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals	Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.

Secondary

Measure	Time frame
Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine	Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.

Countries

United States

Outcome results

None listed

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