Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
Lead Sponsor:
Pulmagen Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B after single and multiple doses in healthy male volunteers.
Eligibility Criteria
Inclusion
- Healthy male subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) of 18 to 30 kg/m2
- Signed and dated written informed consent prior to admission into the study
- Willing and able to comply with the requirements of the protocol and available to complete the study
Exclusion
- Evidence of history of any clinically significant medical disorder
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01173770
Start Date
July 1 2010
End Date
February 1 2011
Last Update
February 2 2011
Active Locations (1)
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1
Simbec
Merthyr Tydfil, United Kingdom, CF48 4DR