FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01173770
Enrollment
52
Registered
2010-08-02
Start date
2010-07-31
Completion date
2011-02-28
Last updated
2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGADC3680B

Escalating single doses ADC3680B or Placebo over 5 study periods

Sponsors

Pulmagen Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs8 days

Secondary

MeasureTime frame
Single dose pharmacokinetics of ADC3680B2 days
Multiple dose pharmacokinetic of ADC3680B8 days
Pharmacokinetics of ADC3680B under fasted and fed conditions2 days
Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivoPre-dose and up to 48 hours post-dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026