A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ADC3680B

• Registration Number: NCT01173770
• Lead Sponsor: Pulmagen Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1: ADC3680B vs. Placebo	ADC3680B	-
Cohort 2: ADC3680B vs. Placebo	ADC3680B	-
Cohort 3: ADC3680B vs Placebo	ADC3680B	-
Cohort 4: ADC3680B vs. Placebo	ADC3680B	-
Cohort 5: ADC3680B vs. Placebo	ADC3680B	-
Cohort 6: ADC3680B	ADC3680B	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs	2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs	8 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Simbec; 🇬🇧 Merthyr Tydfil, United Kingdom