NCT00687232
Completed
Phase 1
A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AZD4818
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of informed consent
- •Body Mass Index (BMI) between 18.0-27.0 kg/m2
- •No clinically relevant abnormal findings
Exclusion Criteria
- •Acute illness which requires medical intervention
- •Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
- •Clinical relevant disease or disorder (past or present)
- •A history of respiratory disorders
Arms & Interventions
1
AZD4818
Intervention: AZD4818
2
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
Time Frame: During the study
Lab assessment
Time Frame: During the study
Secondary Outcomes
- Pharmacokinetics(During the study)
Study Sites (1)
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