InflammationPhase 1NCT01570205
Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers
A Phase 1 study testing XG-102 in people with Inflammation, run by Xigen SA at 1 site in Switzerland.
Trial summary
The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- XG-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2011to Feb 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Age ≥ 18 to ≤ 45 years
- BP: 100 - 150 mm Hg systolic, 50 - 95 mm Hg diastolic and pulse rate: 50 - 100 bpm.
- Body mass index between 18.5 and 30.0 kg/m2 and body weight in the 50 - 100 kg range.
- Are able to communicate and co-operate with the Investigator and his/her staff
- Healthy on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings
- Written informed consent obtained
- Male subjects with partners of childbearing potential have to use adequate contraception during, and for at least the four weeks after administration of study medication.
Who cannot join
- Heavy smokers, i.e. more than 10 cigarettes per day
- Participation in a clinical trial during the previous 4 weeks
- Loss of 500 mL blood or more during the 3 month period before the screening visit of the study
- Existence of any surgical or medical condition which might relevantly interfere with the subject safety, the distribution, metabolism or excretion of the drug or the study assessments, i.e. impaired renal or hepatic function, diabetes mellitus, thyroid function abnormalities including abnormal thyroid hormone values in the Screening evaluation, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
- History of alcohol or drug abuse in the last 3 years.
- Positive results of the drug Screening.
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- Clinically significant abnormal laboratory values at the Screening or baseline evaluation.
- A history of any serious adverse reaction or hypersensitivity to any drug or other medicines
- Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis which requires no treatment may be tolerated).
- Positive results from serology examination for HBV, HCV, HIV or tuberculosis
- History of serious mental disorders.
- Need of any prescription medication within 30 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
- Volunteers who are unwilling to comply with the provisions of this protocol
- Symptoms of a significant (upon Investigator's medical judgment) somatic or mental illness in the two week period preceding drug administration.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Covance Clinical Research
Allschwil, Canton of Basel-City, 4123
About this study
Official title: The Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Male Volunteers in a Randomized, Double Blind, Placebo Controlled, Dose Escalating Phase I Study
The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers
- Conditions
- Inflammation
- Being tested
- XG-102
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XG-102Drug
single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| XG-102 10 µg/kg | Experimental | Not described Receives: Drug: XG-102 |
| XG-102 40 µg/kg | Experimental | Not described Receives: Drug: XG-102 |
| XG-102 80 µg/kg | Experimental | Not described Receives: Drug: XG-102 |
| placebo | Placebo comparator | Not described Receives: Drug: XG-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of XG-102
Safety of XG-102 assessed by incidence and intensity of adverse events, clinical laboratory evaluations, vital signs, ECG, phaysical examination, ocular examination
Measured: 1 month
Secondary outcomes (1)
Pharmacokinetics
Pharmacokinetic profile will be evaluated by determination of Cmax, AUC, Half-life, Clearance , Volume of distribution
Measured: 16 time-points up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xigen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Seiberling, MD, Principal investigator, Covance Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570205
- Sponsor's protocol ID
- SDD-1002-024
- Status last verified
- Apr 2012
- First submitted
- 29 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Male Volunteers in a Randomized, Double Blind, Placebo Controlled, Dose Escalating Phase I Study
- ClinicalTrials.gov ID
- NCT01570205
- Acronym / sponsor ID
- SDD-1002-024
- Conditions
- Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Xigen SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Apr 2012 (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.
The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XG-102 10 µg/kg | Experimental | Drug: XG-102 |
| XG-102 40 µg/kg | Experimental | Drug: XG-102 |
| XG-102 80 µg/kg | Experimental | Drug: XG-102 |
| placebo | Placebo comparator | Drug: XG-102 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male volunteers
- Age ≥ 18 to ≤ 45 years
- BP: 100 - 150 mm Hg systolic, 50 - 95 mm Hg diastolic and pulse rate: 50 - 100 bpm.
- Body mass index between 18.5 and 30.0 kg/m2 and body weight in the 50 - 100 kg range.
- Are able to communicate and co-operate with the Investigator and his/her staff
Key exclusion criteria (14 listed)
- Heavy smokers, i.e. more than 10 cigarettes per day
- Participation in a clinical trial during the previous 4 weeks
- Loss of 500 mL blood or more during the 3 month period before the screening visit of the study
- Existence of any surgical or medical condition which might relevantly interfere with the subject safety, the distribution, metabolism or excretion of the drug or the study assessments, i.e. impaired renal or hepatic function, diabetes mellitus, thyroid function abnormalities including abnormal thyroid hormone values in the Screening evaluation, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
- History of alcohol or drug abuse in the last 3 years.
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 |
|---|---|---|
| XG-102single intravenous infusion | Drug | XG-102 10 µg/kg, XG-102 40 µg/kg, XG-102 80 µg/kg, placebo |
Primary outcome
Safety of XG-102
Time frame: 1 month
Safety of XG-102 assessed by incidence and intensity of adverse events, clinical laboratory evaluations, vital signs, ECG, phaysical examination, ocular examination
1 secondary outcome
Pharmacokinetics
Time frame: 16 time-points up to 24 hours
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 4 Apr 2012.
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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.
Michael Seiberling, MD principal investigator
Covance Clinical 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 XG-102 in people with Inflammation, run by Xigen SA at 1 site in Switzerland.
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 8 inclusion and 14 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 4 Apr 2012. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 of XG-102 (time frame: 1 month). 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 4 Apr 2012.