Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29

NCT01319903 | Completed Phase 1

• 2 other identifiers: IFX-1-P1.12010-023647-15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 pharmacokinetic and pharmacodynamic parameters.

Conditions

Drug Safety

Keywords

sepsis; inflammation; complement; immune system

Outcome Measures

Primary Outcomes (1)

• 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

  pre-dose, days 1,2,3,7,14,28 and 70

Secondary Outcomes (3)

• Assessment of pharmacokinetic parameters of CaCP29 over time

  pre-dose, day 1,2,3,7, 14, 28 and 70

• Number of Participants developing anti-CaCP29 antibodies - Immunogenicity

  pre-dose, days 28 and 70

• Bioactivity of CaCP29 in human whole blood over time after injection

  pre-dose, days 1,2,3,7,14,28 and 70

Interventions

CaCP29, a humanized monoclonal antibody BIOLOGICAL

CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (1)

FOCUS Clinical Drug Development GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Sepsis; Inflammation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grit Andersen, MD

  FOCUS Clinical Drug Development GmbH Stresemannallee 6 41460 Neuss Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 13, 2012

Record last verified: 2012-01

Locations

DE (1)