Trial Outcomes & Findings for Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa (NCT NCT00638365)
NCT ID: NCT00638365
Last Updated: 2014-06-09
Results Overview
Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Day 28
Results posted on
2014-06-09
Participant Flow
This was a multicenter, randomized, double-blind, placebo-controlled safety and PK study.
Two cohorts of subjects were randomized 2:1 and received a single intravenous (IV) infusion of KB001 or Placebo. Cohort 1 received KB001 at 3 mg/kg. Cohort 2 was enrolled at 10 mg/kg. The Placebo groups were combined for analysis.
Participant milestones
| Measure |
Placebo
|
KB001, 3 mg/kg
|
KB001, 10 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
|
KB001, 3 mg/kg
n=10 Participants
|
KB001, 10 mg/kg
n=8 Participants
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Safety population: all subjects randomized and receiving any study medication.
Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.
Outcome measures
| Measure |
Placebo
n=9 Participants
|
KB001, 3 mg/kg
n=10 Participants
|
KB001, 10 mg/kg
n=8 Participants
|
|---|---|---|---|
|
The Safety and Tolerability of a Single-dose of KB001.
|
7 Number of participants experiencing AEs
|
10 Number of participants experiencing AEs
|
8 Number of participants experiencing AEs
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
KB001, 3 mg/kg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
KB001, 10 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
|
KB001, 3 mg/kg
n=10 participants at risk
|
KB001, 10 mg/kg
n=8 participants at risk
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
|
KB001, 3 mg/kg
n=10 participants at risk
|
KB001, 10 mg/kg
n=8 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Investigations
Breath Sounds Abnormal
|
22.2%
2/9 • Number of events 2 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
General disorders
Chest Discomfort
|
0.00%
0/9 • 56 Days
|
20.0%
2/10 • Number of events 2 • 56 Days
|
25.0%
2/8 • Number of events 2 • 56 Days
|
|
General disorders
Chills
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 56 Days
|
30.0%
3/10 • Number of events 3 • 56 Days
|
37.5%
3/8 • Number of events 3 • 56 Days
|
|
General disorders
Crepitations
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 2 • 56 Days
|
|
Congenital, familial and genetic disorders
Cystic Fibrosis Lung
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • Number of events 2 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Investigations
Forced Expiratory Volume Decreased
|
0.00%
0/9 • 56 Days
|
40.0%
4/10 • Number of events 6 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis (hemoptysis)
|
11.1%
1/9 • Number of events 1 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
37.5%
3/8 • Number of events 4 • 56 Days
|
|
Investigations
Heart Rate Increased
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
General disorders
Infusion Site Discolouration
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
General disorders
Infusion Site Rash
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
General disorders
Irritability
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
11.1%
1/9 • Number of events 1 • 56 Days
|
20.0%
2/10 • Number of events 2 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Oral Pruritus
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryingeal Pain
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 2 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
General disorders
Pyrexia (fever)
|
11.1%
1/9 • Number of events 1 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
11.1%
1/9 • Number of events 1 • 56 Days
|
0.00%
0/10 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 2 • 56 Days
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 2 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Psychiatric disorders
Stress
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/9 • 56 Days
|
20.0%
2/10 • Number of events 2 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • 56 Days
|
10.0%
1/10 • Number of events 1 • 56 Days
|
0.00%
0/8 • 56 Days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 56 Days
|
0.00%
0/10 • 56 Days
|
12.5%
1/8 • Number of events 1 • 56 Days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 1 • 56 Days
|
40.0%
4/10 • Number of events 4 • 56 Days
|
25.0%
2/8 • Number of events 2 • 56 Days
|
Additional Information
Nestor A. Molfino, MD., MSc
KaloBios Pharmaceuticals, Inc.
Phone: 650-243-3103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor has right of first publication of trial results, which will be a joint, multi-center publication of the study results from all appropriate sites contributing data, analysis and comments.
- Publication restrictions are in place
Restriction type: OTHER