Drug SafetyPhase 1NCT01319903
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
A Phase 1 study testing CaCP29, a humanized monoclonal antibody in people with Drug Safety, run by InflaRx GmbH at 1 site in Germany.
Trial summary
The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis. Purpose of this phase I clinical trial in healthy human males is to investigate various parameters concerning safety and tolerability of CaCP29 and assess… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- CaCP29, a humanized monoclonal antibody
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Oct 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, Caucasian subjects aged between 18-40 years (inclusive)
- Healthy subjects as determined by medical history, physical examination
- Body weight between 70 - 100 kg and BMI between 19 and 29 kg/m2, extremes incl
- ECG recording based on a 12-lead ECG which is normal (PR < 210 ms, QRS <110 ms, QTC 380 -430 ms) or contains only slight deviations
- Normal vital signs (after 5 minutes resting), blood pressure values (systolic > or equal to 100 and < or equal to 140 mmHg, diastolic > or equal to 50 and < or equal to 90 mmHg), heart rate between 45 and 90 beats per minute (bpm), body temperature < 37.5°C
- Subjects who are able and willing to give written informed consent
- Normal white blood cell count, CRP and IL-6 at screening and Day -1
- Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following dosing
Who cannot join
- In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases;
- Infection or known inflammatory process;
- Known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency;
- Clinical significant allergic disease;
- Known serum hepatitis or who are carriers of the Hepatitis B surface antigen or Hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies;
- Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after the last dose of study drug;
Show all 16Show fewer
- Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents;
- The use of any concomitant prescription or non-prescription medication within 14 days prior to the first administration of study medication until follow-up; or treatment with medication that may affect immune function (e.g. immunoglobulins, corticosteroids) within 6 months before dosing;
- Donation of blood (>400 ml) or blood products within the last 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to study start;
- Definite or suspected personal history of adverse reactions or hypersensitivity to drugs especially to the ingredients of the trial compound or to compounds with a similar structure;
- Use of more than 5 cups or glasses of coffee, tea and / or cola per day;
- Presence or history of drug and/or alcohol abuse or an average daily intake of more than 20 g alcohol per day;
- Positive test for alcohol or drugs at screening and/or on Day -1;
- Smokers of > 5 cigarettes/day or equivalent;
- Subjects who are unlikely to be compliant and attend scheduled clinic visits as required;
- Participation in this study on a previous dose level
Trial locations and contacts
1 site in 1 country.
Germany1 site
FOCUS Clinical Drug Development GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: A Single Ascending, Placebo-controlled, Double-blind Study in Healthy Male Subjects to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the New Humanized Monoclonal Antibody CaCP29
The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis. Purpose of this phase I clinical trial in healthy human males is to investigate various parameters concerning safety and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.
Read the detailed description
The acute inflammatory innate host response, as being present during the development of sepsis and various other acute inflammatory diseases, represents a powerful mechanisms which can lead to destruction of host tissue and severe organ dysfunction. CaCP29 was developed to lower the complement mediated acute inflammatory response and thereby control the extend of a strongly activated often times self-destructive inflammatory response by controlling activation of a key inflammatory mechanism.
- Conditions
- Drug Safety
- Being tested
- CaCP29, a humanized monoclonal antibody
- Keywords
- sepsis, inflammation, complement, immune system
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaCP29, a humanized monoclonal antibodyBiological
CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and extent of changes in safety relevant parameters after injection of CaCP29
Safety relevant parameters include changes from baseline of:
- cytokine levels over time (IL-6, IL-8, IFN-gamma, TNF-alpha, IL-10)
- CH50 activity over time
- standard hematology, clinical chemistry and coagulation laboratory parameters
- 12-lead ECG
- vital signs
Measured: pre-dose, days 1,2,3,7,14,28 and 70
Secondary outcomes (3)
Assessment of pharmacokinetic parameters of CaCP29 over time
- Area under the plasma concentration versus time curve (AUC) of CaCP29
- Peak Plasma Concentration (Cmax) of CaCP29 and time to reach Cmax
- terminal phase half-life
- clearance
- volume of distribution during the terminal phase
Measured: pre-dose, day 1,2,3,7, 14, 28 and 70
Number of Participants developing anti-CaCP29 antibodies - Immunogenicity
Measured: pre-dose, days 28 and 70
Bioactivity of CaCP29 in human whole blood over time after injection
Measured: pre-dose, days 1,2,3,7,14,28 and 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- InflaRx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, FOCUS Clinical Drug Development GmbH Stresemannallee 6 41460 Neuss Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319903
- Sponsor's protocol ID
- IFX-1-P1.1
- Other IDs
- 2010-023647-15
- Status last verified
- Jan 2012
- First submitted
- 18 Mar 2011
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending, Placebo-controlled, Double-blind Study in Healthy Male Subjects to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the New Humanized Monoclonal Antibody CaCP29
- ClinicalTrials.gov ID
- NCT01319903
- Acronym / sponsor ID
- IFX-1-P1.1
- Conditions
- Drug Safety
- Keywords
- sepsis, inflammation, complement, immune system
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- InflaRx GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Mar 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 novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis. Purpose of this phase I clinical trial in healthy human males is to investigate various parameters concerning safety and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.
Detailed description
The acute inflammatory innate host response, as being present during the development of sepsis and various other acute inflammatory diseases, represents a powerful mechanisms which can lead to destruction of host tissue and severe organ dysfunction. CaCP29 was developed to lower the complement mediated acute inflammatory response and thereby control the extend of a strongly activated often times self-destructive inflammatory response by controlling activation of a key inflammatory mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male, Caucasian subjects aged between 18-40 years (inclusive)
- Healthy subjects as determined by medical history, physical examination
- Body weight between 70 - 100 kg and BMI between 19 and 29 kg/m2, extremes incl
- ECG recording based on a 12-lead ECG which is normal (PR < 210 ms, QRS <110 ms, QTC 380 -430 ms) or contains only slight deviations
- Normal vital signs (after 5 minutes resting), blood pressure values (systolic > or equal to 100 and < or equal to 140 mmHg, diastolic > or equal to 50 and < or equal to 90 mmHg), heart rate between 45 and 90 beats per minute (bpm), body temperature < 37.5°C
Key exclusion criteria (16 listed)
- In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases;
- Infection or known inflammatory process;
- Known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency;
- Clinical significant allergic disease;
- Known serum hepatitis or who are carriers of the Hepatitis B surface antigen or Hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies;
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 |
|---|---|---|
| CaCP29, a humanized monoclonal antibodyCaCP29 or placebo single i.v. infusion in ascending doses in healthy human males | Biological | – |
Primary outcome
Number and extent of changes in safety relevant parameters after injection of CaCP29
Time frame: pre-dose, days 1,2,3,7,14,28 and 70
Safety relevant parameters include changes from baseline of: * cytokine levels over time (IL-6, IL-8, IFN-gamma, TNF-alpha, IL-10) * CH50 activity over time * standard hematology, clinical chemistry and coagulation laboratory parameters * 12-lead ECG * vital signs
3 secondary outcomes
Assessment of pharmacokinetic parameters of CaCP29 over time
Time frame: pre-dose, day 1,2,3,7, 14, 28 and 70
Number of Participants developing anti-CaCP29 antibodies - Immunogenicity
Time frame: pre-dose, days 28 and 70
Bioactivity of CaCP29 in human whole blood over time after injection
Time frame: pre-dose, days 1,2,3,7,14,28 and 70
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 13 Jan 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.
Grit Andersen, MD principal investigator
FOCUS Clinical Drug Development GmbH Stresemannallee 6 41460 Neuss Germany
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 CaCP29, a humanized monoclonal antibody in people with Drug Safety, run by InflaRx GmbH 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 8 inclusion and 16 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 13 Jan 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 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?
Number and extent of changes in safety relevant parameters after injection of CaCP29 (time frame: pre-dose, days 1,2,3,7,14,28 and 70). 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 13 Jan 2012.