- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01319903
Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29
January 12, 2012 updated by: InflaRx GmbH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nordrhein-Westfalen
-
Neuss, Nordrhein-Westfalen, Germany, 41460
- FOCUS Clinical Drug Development GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
pre-dose, days 1,2,3,7,14,28 and 70
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of pharmacokinetic parameters of CaCP29 over time
Time Frame: pre-dose, day 1,2,3,7, 14, 28 and 70
|
|
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
|
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
|
pre-dose, days 1,2,3,7,14,28 and 70
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grit Andersen, MD, FOCUS Clinical Drug Development GmbH Stresemannallee 6 41460 Neuss Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
March 18, 2011
First Submitted That Met QC Criteria
March 21, 2011
First Posted (Estimate)
March 22, 2011
Study Record Updates
Last Update Posted (Estimate)
January 13, 2012
Last Update Submitted That Met QC Criteria
January 12, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFX-1-P1.1
- 2010-023647-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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