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Completed

NCT Number: NCT01173770

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Simbec

Merthyr Tydfil, CF48 4DR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADC3680B

Drug

Escalating single doses ADC3680B or Placebo over 5 study periods

Primary outcomes

  1. Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs

    Time frame: 2 days

  2. 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

  1. Single dose pharmacokinetics of ADC3680B

    Time frame: 2 days

  2. Multiple dose pharmacokinetic of ADC3680B

    Time frame: 8 days

  3. Pharmacokinetics of ADC3680B under fasted and fed conditions

    Time frame: 2 days

  4. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Pulmagen Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2010
Registry last updated
Feb 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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