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

Pulmagen Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ADC3680B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01173770

ADC3680-01

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 6 patient groups

Cohort 1: ADC3680B vs. Placebo

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B

Cohort 2: ADC3680B vs. Placebo

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B

Cohort 3: ADC3680B vs Placebo

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B

Cohort 4: ADC3680B vs. Placebo

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B

Cohort 5: ADC3680B vs. Placebo

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B

Cohort 6: ADC3680B

Experimental group

Treatment:

Drug: ADC3680B

Drug: ADC3680B

Drug: ADC3680B