A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
NCT01173770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2011-02-02
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
- DRUG
-
ADC3680B
ADC3680B or Placebo for 7 days
- DRUG
-
ADC3680B
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Sponsors & Collaborators
-
Pulmagen Therapeutics
lead INDUSTRY
Principal Investigators
-
Febbraro · Simbec Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2011-02-28
- Completion
- 2011-02-28
Countries
- United Kingdom
Study Locations
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