Phase 2
N=27
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00638365 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Aug 2011
Primary outcome: Primary: The Safety and Tolerability of a Single-dose of KB001. — 7; 10; 8 Number of participants experiencing AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KB001 (Biological); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Humanigen, Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety and Tolerability of a Single-dose of KB001. |
7; 10; 8 | — |
Summary
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Confirmed diagnosis of CF based on the following criteria:
Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype
- Age >/= 18 years of age with the potential for age 12 >/=
- Screening Pa sputum culture
- 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)
Exclusion Criteria
- Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
- Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
- History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
- Current cigarette smoker, history of drug addiction or alcohol abuse
- Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
- Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study
Data sourced from ClinicalTrials.gov (NCT00638365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.