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

Pulmagen Therapeutics52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ADC3680BDRUG

Escalating single doses ADC3680B or Placebo over 5 study periods

ADC3680BDRUG

ADC3680B or Placebo for 7 days

ADC3680BDRUG

Single doses ADC3680B over 2 study periods under fasted and fed conditions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Simbec

Merthyr Tydfil, United Kingdom

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

Time frame: 2 days

Multiple dose pharmacokinetic of ADC3680B

Time frame: 8 days

Pharmacokinetics of ADC3680B under fasted and fed conditions

Time frame: 2 days

Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo

Time frame: Pre-dose and up to 48 hours post-dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.