HealthyPhase 1NCT01510782
Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers
A Phase 1 study testing BI 655064 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of… 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
- What is being tested?
- BI 655064
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy male subjects
Who cannot join
- 1. Any relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.
- Conditions
- Healthy
- Being tested
- Placebo to BI 655064, BI 655064
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to BI 655064Drug
intravenous infusion of escalating doses
Placebo to BI 655064Drug
subcutaneous injection of escalating doses
BI 655064Drug
intravenous infusion of escalating doses
BI 655064Drug
subcutaneous injection of escalating doses
| Study group | Role | What they receive |
|---|---|---|
| BI 655064 subcutaneous | Experimental | Escalating single dose as solution for subcutaneous injection Receives: Drug: BI 655064 |
| Placebo to BI 655064 subcutaneous | Placebo comparator | Escalation single dose as solution for subcutaneous injection (Placebo) Receives: Drug: Placebo to BI 655064 |
| BI 655064 intravenous | Experimental | Escalating single dose as solution for intravenous infusion Receives: Drug: BI 655064 |
| Placebo to BI 655064 intravenous | Placebo comparator | Escalating single dose as solution for intravenous infusion (Placebo) Receives: Drug: Placebo to BI 655064 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vital signs (blood pressure [BP], pulse rate [PR])
Measured: up to 70 days post treatment
Changes in 12-lead ECG (electrocardiogram)
Measured: up to 70 days post treatment
Incidence of adverse events
Measured: up to 70 days post treatment
Assessment of global tolerability by investigator
Measured: up to 70 days post treatment
Assessment of local tolerability by investigator
Measured: up to 70 days post treatment
Secondary outcomes (3)
Maximum measured concentration of the analyte in plasma
Measured: up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose
Measured: up to 1656 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510782
- Sponsor's protocol ID
- 1293.1
- Other IDs
- 2011-002251-34
- Status last verified
- Oct 2013
- First submitted
- 12 Jan 2012
- Last updated
- 1 Nov 2013
- Results posted
- No
Publications
Albach FN, Wagner F, Huser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10.
PubMed 29127458
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT01510782
- Acronym / sponsor ID
- 1293.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Jan 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.
To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 655064 subcutaneous | Experimental | Drug: BI 655064Escalating single dose as solution for subcutaneous injection |
| Placebo to BI 655064 subcutaneous | Placebo comparator | Drug: Placebo to BI 655064Escalation single dose as solution for subcutaneous injection (Placebo) |
| BI 655064 intravenous | Experimental | Drug: BI 655064Escalating single dose as solution for intravenous infusion |
| Placebo to BI 655064 intravenous | Placebo comparator | Drug: Placebo to BI 655064Escalating single dose as solution for intravenous infusion (Placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy male subjects
Key exclusion criteria (1 listed)
- 1. Any relevant deviation from healthy conditions
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 |
|---|---|---|
| Placebo to BI 655064intravenous infusion of escalating doses | Drug | Placebo to BI 655064 intravenous |
| Placebo to BI 655064subcutaneous injection of escalating doses | Drug | Placebo to BI 655064 subcutaneous |
| BI 655064intravenous infusion of escalating doses | Drug | BI 655064 intravenous |
| BI 655064subcutaneous injection of escalating doses | Drug | BI 655064 subcutaneous |
Primary outcome
Changes in vital signs (blood pressure [BP], pulse rate [PR])
Time frame: up to 70 days post treatment
Changes in 12-lead ECG (electrocardiogram)
Time frame: up to 70 days post treatment
Incidence of adverse events
Time frame: up to 70 days post treatment
Assessment of global tolerability by investigator
Time frame: up to 70 days post treatment
Assessment of local tolerability by investigator
Time frame: up to 70 days post treatment
3 secondary outcomes
Maximum measured concentration of the analyte in plasma
Time frame: up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose
Time frame: up to 1656 hours post treatment
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 1 Nov 2013.
- Derived from this study: PubMed 29127458Albach FN, Wagner F, Huser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 BI 655064 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 1 inclusion and 1 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 1 Nov 2013. 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 Germany. 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?
Changes in vital signs (blood pressure [BP], pulse rate [PR]) (time frame: up to 70 days post treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510782, which also lists 1 linked publication.
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 1 Nov 2013.