Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAT-354 · 3 trials · 2 indications
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
The safety and tolerability of a single dose SC injection of CAT-354 in healthy male and/or female Japanese subjects will be assessed through the incidence of adverse events (AEs), and the assessment of vital signs, physical examinations, laboratory parameters, and electrocardiograms.
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).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | EXPERIMENTAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | EXPERIMENTAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | EXPERIMENTAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| Cohort 1 | EXPERIMENTAL | CAT-354 will be administered by SC injection |
| Cohort 2 | EXPERIMENTAL | CAT-354 will be administered by SC injection |
| Cohort 3 | EXPERIMENTAL | CAT-354 will be administered by SC injection |
| CAT-354 150 mg (intravenous) | EXPERIMENTAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | EXPERIMENTAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 150 mg | BIOLOGICAL | CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 300 mg | BIOLOGICAL | CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 600 mg | BIOLOGICAL | CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. |
| CAT-354 | DRUG | 150 mg CAT-354 or placebo given SC on Day 1 |
| CAT 354 | DRUG | 600 mg CAT-354 or placebo given SC on Day 1 |
| CAT-354 150 mg (intravenous) | BIOLOGICAL | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| CAT-354 150 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
| CAT-354 300 mg (subcutaneous) | BIOLOGICAL | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
Inclusion Criteria: * Male or female subjects * Age 18 to 65 years at the time of Screening * Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2) * Written informed consent obtained from the subject prior to performing any protocol related procedures, in...
CAT-354 is an investigational monoclonal antibody being studied for the treatment of asthma. It has been evaluated in clinical trials involving patients with asthma as well as healthy volunteers to assess its safety, efficacy, and pharmacokinetics.
CAT-354 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials to evaluate the drug's safety and efficacy in asthma.
CAT-354 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study that enrolled 357 participants with asthma to evaluate the drug's safety and efficacy.
CAT-354 has been studied in three completed clinical trials. These include NCT00638989, a Phase 1 study in healthy volunteers and asthma patients; NCT00873860, a Phase 2 efficacy and safety study in asthma; and NCT01093040, a Phase 1 study in healthy Japanese subjects.
CAT-354 is the primary name used for this investigational monoclonal antibody in clinical trials. No alternative names have been reported in the available clinical trial information.