NCT01173770CompletedPhase 1
A Double-Blind Randomized, Placebo-Controlled, Dose Escalating Study to Assess The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ADC3680B Administered Orally to Healthy Volunteers and to Investigate Food Effects on Pharmacokinetics After Single Oral Doses of ADC3680B
Pulmagen Therapeutics1 site in 1 country52 target enrollmentStarted: July 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •Evidence of history of any clinically significant medical disorder
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Arms & Interventions
Cohort 1: ADC3680B vs. Placebo
Experimental
Intervention: ADC3680B (Drug)
Cohort 2: ADC3680B vs. Placebo
Experimental
Intervention: ADC3680B (Drug)
Cohort 3: ADC3680B vs Placebo
Experimental
Intervention: ADC3680B (Drug)
Cohort 4: ADC3680B vs. Placebo
Experimental
Intervention: ADC3680B (Drug)
Cohort 5: ADC3680B vs. Placebo
Experimental
Intervention: ADC3680B (Drug)
Cohort 6: ADC3680B
Experimental
Intervention: ADC3680B (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Time Frame: 2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Time Frame: 8 days
Secondary Outcomes
- Single dose pharmacokinetics of ADC3680B(2 days)
- Multiple dose pharmacokinetic of ADC3680B(8 days)
- Pharmacokinetics of ADC3680B under fasted and fed conditions(2 days)
- Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo(Pre-dose and up to 48 hours post-dose)
Investigators
Study Sites (1)
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