HealthyPhase 1NCT01378364
Phase I Study of AbGn-168H in Healthy Male Volunteers
A Phase 1 study testing AbGn-168H in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AbGn-168H
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Nov 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
- Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Use of biologic agents within 12 weeks prior to treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics Study of Single Rising Doses of AbGn-168H Administered by Intravenous Infusion (125 μg/kg, 500 μg/kg, 1 mg/kg, 2 mg/kg) or Subcutaneous Injection (125 μg/kg, 1 mg/kg) to Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.
- Conditions
- Healthy
- Being tested
- AbGn-168H, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn-168HDrug
single very low dose of AbGn-168H i.v.
AbGn-168HDrug
single low dose of AbGn-168H i.v.
PlaceboDrug
single dose of Placebo i.v.
PlaceboDrug
single dose of Placebo i.v.
PlaceboDrug
single dose of Placebo i.v.
PlaceboDrug
single dose of Placebo i.v.
AbGn-168HDrug
single medium dose of AbGn-168H i.v.
AbGn-168HDrug
single high dose of AbGn-168H i.v.
AbGn-168HDrug
single low dose of AbGn-168H s.c.
PlaceboDrug
single dose of Placebo s.c.
PlaceboDrug
single dose of Placebo s.c.
AbGn-168HDrug
single medium dose of AbGn-168H s.c.
| Study group | Role | What they receive |
|---|---|---|
| AbGn-168H very low dose i.v. | Experimental | subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo Receives: Drug: AbGn-168H; Drug: Placebo |
| AbGn-168H low dose i.v. | Experimental | subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo Receives: Drug: AbGn-168H; Drug: Placebo |
| AbGn-168H medium dose i.v. | Experimental | subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo Receives: Drug: Placebo; Drug: AbGn-168H |
| AbGn-168H high dose i.v. | Experimental | subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo Receives: Drug: Placebo; Drug: AbGn-168H |
| AbGn-168H very low dose s.c. | Experimental | subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo Receives: Drug: AbGn-168H; Drug: Placebo |
| AbGn-168H medium dose s.c. | Experimental | subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo Receives: Drug: Placebo; Drug: AbGn-168H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator
Measured: 6 weeks
Secondary outcomes (14)
MRT sc (mean residence time of the analyte in the body after subcutaneous injection)
Measured: 6 weeks
CL (total/apparent clearance of the analyte in plasma after intravascular administration)
Measured: 6 weeks
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Measured: 6 weeks
V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)
Measured: 6 weeks
V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)
Measured: 6 weeks
V ss (apparent volume of distribution at steady state following intravascular administration)
Measured: 6 weeks
C max (maximum measured concentration of the analyte in plasma)
Measured: 6 weeks
t max (time from dosing to maximum measured concentration)
Measured: 6 weeks
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 6 weeks
AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured
Measured: 6 weeks
%AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint
Measured: 6 weeks
delta z (terminal rate constant in plasma)
Measured: 6 weeks
t 1/2 (terminal half-life of the analyte in plasma)
Measured: 6 weeks
MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 48 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
- NCT01378364
- Sponsor's protocol ID
- 1304.1
- Other IDs
- 2011-000713-39
- Status last verified
- Oct 2013
- First submitted
- 21 Jun 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
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 and Pharmacokinetics Study of Single Rising Doses of AbGn-168H Administered by Intravenous Infusion (125 μg/kg, 500 μg/kg, 1 mg/kg, 2 mg/kg) or Subcutaneous Injection (125 μg/kg, 1 mg/kg) to Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01378364
- Acronym / sponsor ID
- 1304.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- First posted
- 22 Jun 2011 (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 aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AbGn-168H very low dose i.v. | Experimental | Drug: AbGn-168H, Drug: Placebosubject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo |
| AbGn-168H low dose i.v. | Experimental | Drug: AbGn-168H, Drug: Placebosubject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo |
| AbGn-168H medium dose i.v. | Experimental | Drug: Placebo, Drug: AbGn-168Hsubject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo |
| AbGn-168H high dose i.v. | Experimental | Drug: Placebo, Drug: AbGn-168Hsubject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo |
| AbGn-168H very low dose s.c. | Experimental | Drug: AbGn-168H, Drug: Placebosubject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo |
| AbGn-168H medium dose s.c. | Experimental | Drug: Placebo, Drug: AbGn-168Hsubject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Key exclusion criteria (6 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
- Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
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 |
|---|---|---|
| AbGn-168Hsingle very low dose of AbGn-168H i.v. | Drug | AbGn-168H very low dose i.v. |
| AbGn-168Hsingle low dose of AbGn-168H i.v. | Drug | AbGn-168H low dose i.v. |
| Placebosingle dose of Placebo i.v. | Drug | AbGn-168H very low dose i.v. |
| Placebosingle dose of Placebo i.v. | Drug | AbGn-168H low dose i.v. |
| Placebosingle dose of Placebo i.v. | Drug | AbGn-168H medium dose i.v. |
| Placebosingle dose of Placebo i.v. | Drug | AbGn-168H high dose i.v. |
| AbGn-168Hsingle medium dose of AbGn-168H i.v. | Drug | AbGn-168H medium dose i.v. |
| AbGn-168Hsingle high dose of AbGn-168H i.v. | Drug | AbGn-168H high dose i.v. |
| AbGn-168Hsingle low dose of AbGn-168H s.c. | Drug | AbGn-168H very low dose s.c. |
| Placebosingle dose of Placebo s.c. | Drug | AbGn-168H very low dose s.c. |
| Placebosingle dose of Placebo s.c. | Drug | AbGn-168H medium dose s.c. |
| AbGn-168Hsingle medium dose of AbGn-168H s.c. | Drug | AbGn-168H medium dose s.c. |
Primary outcome
Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator
Time frame: 6 weeks
14 secondary outcomes
MRT sc (mean residence time of the analyte in the body after subcutaneous injection)
Time frame: 6 weeks
CL (total/apparent clearance of the analyte in plasma after intravascular administration)
Time frame: 6 weeks
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: 6 weeks
V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)
Time frame: 6 weeks
V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)
Time frame: 6 weeks
V ss (apparent volume of distribution at steady state following intravascular administration)
Time frame: 6 weeks
C max (maximum measured concentration of the analyte in plasma)
Time frame: 6 weeks
t max (time from dosing to maximum measured concentration)
Time frame: 6 weeks
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 6 weeks
AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured
Time frame: 6 weeks
%AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint
Time frame: 6 weeks
delta z (terminal rate constant in plasma)
Time frame: 6 weeks
t 1/2 (terminal half-life of the analyte in plasma)
Time frame: 6 weeks
MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion)
Time frame: 6 weeks
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.
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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 AbGn-168H 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 4 inclusion and 6 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. 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 will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator (time frame: 6 weeks). 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 1 Nov 2013.