Healthy VolunteersPhase 1NCT01173770
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
A Phase 1 study testing ADC3680B in people with Healthy Volunteers, run by Pulmagen Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ADC3680B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Evidence of history of any clinically significant medical disorder
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- ADC3680B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ADC3680B vs. Placebo | Experimental | Not described Receives: Drug: ADC3680B |
| Cohort 2: ADC3680B vs. Placebo | Experimental | Not described Receives: Drug: ADC3680B |
| Cohort 3: ADC3680B vs Placebo | Experimental | Not described Receives: Drug: ADC3680B |
| Cohort 4: ADC3680B vs. Placebo | Experimental | Not described Receives: Drug: ADC3680B |
| Cohort 5: ADC3680B vs. Placebo | Experimental | Not described Receives: Drug: ADC3680B |
| Cohort 6: ADC3680B | Experimental | Not described Receives: Drug: ADC3680B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Measured: 2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Measured: 8 days
Secondary outcomes (4)
Single dose pharmacokinetics of ADC3680B
Measured: 2 days
Multiple dose pharmacokinetic of ADC3680B
Measured: 8 days
Pharmacokinetics of ADC3680B under fasted and fed conditions
Measured: 2 days
Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo
Measured: Pre-dose and up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmagen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Febbraro, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173770
- Sponsor's protocol ID
- ADC3680-01
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01173770
- Acronym / sponsor ID
- ADC3680-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pulmagen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ADC3680B vs. Placebo | Experimental | Drug: ADC3680B |
| Cohort 2: ADC3680B vs. Placebo | Experimental | Drug: ADC3680B |
| Cohort 3: ADC3680B vs Placebo | Experimental | Drug: ADC3680B |
| Cohort 4: ADC3680B vs. Placebo | Experimental | Drug: ADC3680B |
| Cohort 5: ADC3680B vs. Placebo | Experimental | Drug: ADC3680B |
| Cohort 6: ADC3680B | Experimental | Drug: ADC3680B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Evidence of history of any clinically significant medical disorder
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADC3680BEscalating single doses ADC3680B or Placebo over 5 study periods | Drug | Cohort 1: ADC3680B vs. Placebo, Cohort 2: ADC3680B vs. Placebo |
| ADC3680BADC3680B or Placebo for 7 days | Drug | Cohort 3: ADC3680B vs Placebo, Cohort 4: ADC3680B vs. Placebo, Cohort 5: ADC3680B vs. Placebo |
| ADC3680BSingle doses ADC3680B over 2 study periods under fasted and fed conditions | Drug | Cohort 6: ADC3680B |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2011.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Febbraro principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADC3680B in people with Healthy Volunteers, run by Pulmagen Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2011.