A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
NCT ID: NCT01173770
Last Updated: 2011-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2010-07-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort 1: ADC3680B vs. Placebo
ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
Cohort 2: ADC3680B vs. Placebo
ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
Cohort 3: ADC3680B vs Placebo
ADC3680B
ADC3680B or Placebo for 7 days
Cohort 4: ADC3680B vs. Placebo
ADC3680B
ADC3680B or Placebo for 7 days
Cohort 5: ADC3680B vs. Placebo
ADC3680B
ADC3680B or Placebo for 7 days
Cohort 6: ADC3680B
ADC3680B
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Interventions
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ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B
ADC3680B or Placebo for 7 days
ADC3680B
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
18 Years
55 Years
MALE
Yes
Sponsors
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Pulmagen Therapeutics
INDUSTRY
Responsible Party
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Simbec Research Limited
Principal Investigators
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Febbraro
Role: PRINCIPAL_INVESTIGATOR
Simbec Research
Locations
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Simbec
Merthyr Tydfil, , United Kingdom
Countries
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Other Identifiers
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ADC3680-01
Identifier Type: -
Identifier Source: org_study_id
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