Carlos Milla
KaloBios
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
KaloBios is developing a drug called KB001 to treat Pseudomonas aeruginosa (PA) in Cystic Fibrosis (CF) patients. PA is a bacteria that infects people who are prone to lung infections. This research study involves an infusion of KB001, an investigational drug. KB001 is an antibody that blocks virulence elements in PA and is being studied for its ability to assist in the treatment of infection and inflammation in the lungs of CF patients infected with PA. This study is being conducted to learn more about the pharmacokinetics, safety and tolerability of KB001 on CF patients. In addition, exploratory measures of efficacy will be monitored.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: KB001
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
12 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1 Provision of written informed consent (and assent, when applicable) obtained from patient or patient#s legal representative
2 Age ≥18 years for the initial 4 patients in each dosing cohort; age ≥12 pending after confirmation of safety by the DMC from the initial 4 patients
3 Confirmed diagnosis of CF based on the following criteria: # Positive sweat chloride >60 mEq/liter (by pilocarpine iontophoresis) and/or # A genotype with 2 identifiable mutations consistent with CF, and # One or more clinical features consistent with the CF phenotype
4 Screening quantitative sputum culture with ??1 ?? (10)5 cfu/gm sputum of Pseudomonas aeruginosa (PA).
5 FEV1 % predicted ??40 (based on Wang's equations for males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)
Key Exclusion Criteria:
1 Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to Day 0
2 Use of systemic corticosteroids within 4 weeks prior to Day 0
3 Use of systemic antibiotics (oral or IV) for acute illness within 4 weeks prior to Day 0
4 Any change in regimen of CF maintenance therapies (other than cyclic inhaled antibiotics) within 14 days prior to Day 0 including non-steroidal anti-inflammatory agents, oral antibiotics and inhaled rhDNase, hypertonic saline and glucocorticoids
5 Patients who have received a cyclic inhaled antibiotic within 14 days prior to Day 0 who have received less than 12 weeks of dosing of that inhaled antibiotic over the last 6 months
6 Patients continuously on an inhaled antibiotic(s) and unable or unwilling to comply with the requirement to stop use of inhaled antibiotics from Day 0 through Day 28
7 History of poor tolerance of the sputum induction procedure or administration of 3% hypertonic saline
8 History of sputum cultures positive for B. cepacia complex
9 History of organ transplantation
10 Poor venous access
11 Current cigarette smoker
12 History of drug addiction or alcohol abuse
13 Abnormal laboratory results, including: # Hemoglobin ?? 10 gm/dL # Neutrophil count ?? 2.0 ?? 109/L # Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) # Serum creatinine >2 times ULN
14 History of hepatic disease (clinical cirrhosis and/or portal hypertension), or renal dysfunction, or any clinically significant, uncontrolled medical condition considered by the Investigator to be high risk for participation in an investigational study
15 Use of an investigational medication or participation in an investigational study within 4 weeks prior to Day 0
16 Women who are breast feeding or who are pregnant, as evidenced by a positive serum or urine pregnancy test for women of childbearing potential
17 Patient and/or partner unwilling to use an effective form of barrier contraceptives during Screening and for 4 weeks after study drug infusion
18 Any other reason, which in the opinion of the Investigator would prevent the patient from completing participation in the study or following the study schedule
Additional Study Details
Official Title:
A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001-in Cystic Fibrosis Patients Infected with Pseudomonas aeruginosaAnticipated start date:
3/5/2008Lead Sponsor:
KaloBios Pharmaceuticals, Inc.Investigator(s):
- Carlos Milla
- Carol K. Conrad
- Richard B Moss
- Paul K Mohabir
- Daya Upadhyay
- John David Mark
- Martha Hamilton
- Terry Earl Robinson
- Zoe Davies RN
- Colleen Dunn RCP
- Daisy Carolina Diaz
- Yan Ki Angela Leung
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- The primary endpoint in this trial is incidence and severity of treatment related Adverse Events.
Secondary Outcomes:
- We will also evaluate the change from baseline of the following:
- Sputum microbiology (bacterial counts, sputum microbial ecology, PcrV expression);
- Inflammatory markers (quantity of neutrophils and macrophages, inflammatory mediators, peripheral blood
- neutrophil and serum high sensitivity C-Reactive Protein concentrations);
- Pulmonary Function; Clinical Symptoms; PK; and Immunogenicity.
Total Number to be Enrolled:
48Total Number to be Enrolled at Stanford:
0More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/29/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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