Adults 19 to 55, male only, with Asthma or Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Bioavailability of CAT-354 After Subcutaneous DosePrimary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Group
Value
95% CI
CAT-354 150 mg (Subcutaneous)
62.1
48.5 – 79.6
CAT-354 300 mg (Subcutaneous)
60.1
46.9 – 77.1
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)Secondary· Day 0 to 56
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relati
TEAEs
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
5
CAT-354 150 mg (Subcutaneous)
5
CAT-354 300 mg (Subcutaneous)
4
TESAEs
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
0
CAT-354 150 mg (Subcutaneous)
0
CAT-354 300 mg (Subcutaneous)
0
Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any VisitSecondary· Day 0 and Day 56
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
0
CAT-354 150 mg (Subcutaneous)
0
CAT-354 300 mg (Subcutaneous)
0
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
903
± 291
CAT-354 150 mg (Subcutaneous)
548
± 143
CAT-354 300 mg (Subcutaneous)
1080
± 315
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
765
± 220
CAT-354 150 mg (Subcutaneous)
467
± 122
CAT-354 300 mg (Subcutaneous)
881
± 287
Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC \[0 - infinity\]) was normalized by CAT-354 dose.
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
6.02
± 1.94
CAT-354 150 mg (Subcutaneous)
3.66
± 0.953
CAT-354 300 mg (Subcutaneous)
3.59
± 1.05
Maximum Observed Serum Concentration (Cmax)Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
58.3
± 14.4
CAT-354 150 mg (Subcutaneous)
17.1
± 5.91
CAT-354 300 mg (Subcutaneous)
36.6
± 13.1
Dose Normalized Maximum Observed Concentration (Cmax/Dose)Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
0.389
± 0.096
CAT-354 150 mg (Subcutaneous)
0.114
± 0.039
CAT-354 300 mg (Subcutaneous)
0.122
± 0.044
Time to Reach Maximum Observed Serum Concentration (Tmax)Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
0.063
0.042 – 1.02
CAT-354 150 mg (Subcutaneous)
5
3 – 9
CAT-354 300 mg (Subcutaneous)
5
3 – 9
Terminal Phase Elimination Half Life (t1/2)Secondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
21.4
± 2.46
CAT-354 150 mg (Subcutaneous)
19.2
± 3.1
CAT-354 300 mg (Subcutaneous)
19.4
± 3.59
Apparent Systemic Clearance (CL/F) After Subcutaneous DoseSecondary· Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
Group
Value
95% CI
CAT-354 150 mg (Subcutaneous)
292
± 82.3
CAT-354 300 mg (Subcutaneous)
307
± 109
Apparent Systemic Clearance (CL/F) After Intravenous DoseSecondary· Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Group
Value
95% CI
CAT-354 150 mg (Intravenous)
188
± 84.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 0 to 56.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CAT-354 150 mg (Intravenous)
Serious: 0/10 (0%)
Deaths: —
CAT-354 150 mg (Subcutaneous)
Serious: 0/10 (0%)
Deaths: —
CAT-354 300 mg (Subcutaneous)
Serious: 0/10 (0%)
Deaths: —
Other adverse events (25 terms — click to expand)
Reaction
System
CAT-354 150 mg (Intravenous)
CAT-354 150 mg (Subcutaneo…
CAT-354 300 mg (Subcutaneo…
Headache
Nervous system disorders
—
—
—
Paranasal sinus hype
Respiratory, thoracic and mediastinal disorders
—
—
—
Eye pruritus
Eye disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Feeling cold
General disorders
—
—
—
Feeling hot
General disorders
—
—
—
Post-traumatic pain
Injury, poisoning and procedural complications
—
—
—
Procedural pain
Injury, poisoning and procedural complications
—
—
—
Sunburn
Injury, poisoning and procedural complications
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
Joint swelling
Musculoskeletal and connective tissue disorders
—
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
—
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 4 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00638989.