Drug Safety Clinical Trial
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01425502 -
Data-driven Quality Improvement in Primary Care - Trial
|
N/A | |
| Recruiting |
NCT01756183 -
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
|
Phase 2 | |
| Completed |
NCT01757860 -
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01355016 -
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01179854 -
Remegal Different Doses in Patients With Refractory Partial Seizures
|
Phase 2 | |
| Completed |
NCT00376415 -
A Safety Study of Lessertia Frutescens in Adults.
|
Phase 1 | |
| Active, not recruiting |
NCT01722916 -
Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase
|
Early Phase 1 | |
| Completed |
NCT01727778 -
Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01475097 -
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
|
Phase 4 | |
| Completed |
NCT01412658 -
Clinical Safety of a Novel Milk Protein Peptide
|
Phase 1 | |
| Terminated |
NCT01847222 -
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
|
Phase 1 | |
| Unknown status |
NCT01633099 -
Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients
|
Phase 3 | |
| Recruiting |
NCT01297842 -
Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections
|
Phase 4 | |
| Completed |
NCT01284582 -
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)
|
Phase 1 | |
| Completed |
NCT01557270 -
Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery
|
Phase 3 | |
| Completed |
NCT01556607 -
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
|
Phase 1 | |
| Completed |
NCT01271569 -
A Study to Assess the Efficacy and Safety of Fospropofol Disodium
|
Phase 1 | |
| Recruiting |
NCT04785027 -
Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT01367873 -
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01428882 -
Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy
|
Phase 4 |