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A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma
Phase 1 trial testing CAT-354 1mg/kg in Moderate Asthma in 23 participants. Terminated before completion.
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 29 September 2006 |
| Primary completion | 3 August 2007 |
| Estimated completion | 3 August 2007 |
| Sites | 1 location across United Kingdom |
MedImmune LLC — full company profile →
Adults 18 to 60, any sex, with Moderate Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 30.3 | ± 5.18 |
| CAT-354 5 mg/kg | 156.8 | ± 34.55 |
| CAT-354 10 mg/kg | 306.3 | ± 31.39 |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 35.0 | ± 6.81 |
| CAT-354 5 mg/kg | 161.0 | ± 32.81 |
| CAT-354 10 mg/kg | 298.0 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 41.1 | ± 4.77 |
| CAT-354 5 mg/kg | 178.7 | ± 25.41 |
| CAT-354 10 mg/kg | 393.0 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 299.6 | ± 42.03 |
| CAT-354 5 mg/kg | 1691.3 | ± 302.70 |
| CAT-354 10 mg/kg | 3106.3 | ± 719.25 |
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 428.0 | ± 83.33 |
| CAT-354 5 mg/kg | 2314.3 | ± 392.91 |
| CAT-354 10 mg/kg | 3861.3 | ± 662.42 |
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 16.6 | ± 2.67 |
| CAT-354 5 mg/kg | 16.1 | ± 3.60 |
| CAT-354 10 mg/kg | 11.8 | ± 1.86 |
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 2.41 | ± 0.45 |
| CAT-354 5 mg/kg | 2.23 | ± 0.46 |
| CAT-354 10 mg/kg | 2.64 | ± 0.42 |
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 56.7 | ± 8.04 |
| CAT-354 5 mg/kg | 51.0 | ± 10.36 |
| CAT-354 10 mg/kg | 44.0 | ± 0.79 |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 5.3 | ± 1.33 |
| CAT-354 5 mg/kg | 27.1 | ± 4.91 |
| CAT-354 10 mg/kg | 40.7 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 7.7 | ± 1.63 |
| CAT-354 5 mg/kg | 36.0 | ± 11.51 |
| CAT-354 10 mg/kg | 59.4 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 8.6 | ± 1.99 |
| CAT-354 5 mg/kg | 40.6 | ± 12.26 |
| CAT-354 10 mg/kg | 79.6 | ± NA |
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 first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 8 | |
| CAT-354 5 mg/kg | 8 | |
| CAT-354 10 mg/kg | 3 | |
| Placebp | 4 |
| Group | Value | 95% CI |
|---|---|---|
| CAT-354 1 mg/kg | 0 | |
| CAT-354 5 mg/kg | 1 | |
| CAT-354 10 mg/kg | 0 | |
| Placebp | 0 |
Time frame: Day 0 to 147. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 1 mg/kg | 5 mg/kg | 10 mg/kg | Placebo |
|---|---|---|---|---|---|
| Lower respiratory tract infection | Infections and infestations | — | — | — | — |
| Reaction | System | 1 mg/kg | 5 mg/kg | 10 mg/kg | Placebo |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Blepharospasm | Eye disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Epigastric discomfort | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Chest discomfort | General disorders | — | — | — | — |
| Feeling hot and cold | General disorders | — | — | — | — |
| Infusion site pain | General disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — | — |
| Pertussis | Infections and infestations | — | — | — | — |
| Pyelonephritis | Infections and infestations | — | — | — | — |
| Tonsillitis | Infections and infestations | — | — | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — | — | — |
| Urine analysis abnormal | Investigations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Tendonitis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Disturbance in attention | Nervous system disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Lethargy | Nervous system disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash papular | Skin and subcutaneous tissue disorders | — | — | — | — |
Most-reported serious reactions: Lower respiratory tract infection.
Data from ClinicalTrials.gov NCT00974675 adverse events section.
The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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