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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ADC3680B
* Drug: ADC3680B
* Drug: ADC3680B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: ADC3680B vs. Placebo<br> | Drug: ADC3680B<br>* Escalating single doses ADC3680B or Placebo over 5 study periods<br>|
| Experimental: Cohort 2: ADC3680B vs. Placebo<br> | Drug: ADC3680B<br>* Escalating single doses ADC3680B or Placebo over 5 study periods<br>|
| Experimental: Cohort 3: ADC3680B vs Placebo<br> | Drug: ADC3680B<br>* ADC3680B or Placebo for 7 days<br>|
| Experimental: Cohort 4: ADC3680B vs. Placebo<br> | Drug: ADC3680B<br>* ADC3680B or Placebo for 7 days<br>|
| Experimental: Cohort 5: ADC3680B vs. Placebo<br> | Drug: ADC3680B<br>* ADC3680B or Placebo for 7 days<br>|
| Experimental: Cohort 6: ADC3680B<br> | Drug: ADC3680B<br>* Single doses ADC3680B over 2 study periods under fasted and fed conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |