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

NCT ID: NCT01173770

Last Updated: 2011-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: ADC3680B vs. Placebo

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

Escalating single doses ADC3680B or Placebo over 5 study periods

Cohort 2: ADC3680B vs. Placebo

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

Escalating single doses ADC3680B or Placebo over 5 study periods

Cohort 3: ADC3680B vs Placebo

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

ADC3680B or Placebo for 7 days

Cohort 4: ADC3680B vs. Placebo

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

ADC3680B or Placebo for 7 days

Cohort 5: ADC3680B vs. Placebo

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

ADC3680B or Placebo for 7 days

Cohort 6: ADC3680B

Group Type EXPERIMENTAL

ADC3680B

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADC3680B

Escalating single doses ADC3680B or Placebo over 5 study periods

Intervention Type DRUG

ADC3680B

ADC3680B or Placebo for 7 days

Intervention Type DRUG

ADC3680B

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pulmagen Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Simbec Research Limited

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Febbraro

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Simbec

Merthyr Tydfil, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ADC3680-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase 1 Study of ANAVEX3-71
NCT04442945 COMPLETED PHASE1