Moderate AsthmaPhase 1NCT00974675

A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma

A Phase 1 study testing CAT-354 1mg/kg, CAT-354 5 mg/kg and CAT-354 10mg/kg in people with Moderate Asthma, run by MedImmune LLC at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Moderate Asthma
What is being tested?: CAT-354 1mg/kg, CAT-354 5 mg/kg and CAT-354 10mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited Kingdom
Study dates: 29 Sep 2006to 3 Aug 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Males or infertile females
Subjects with asthma, well controlled on inhaled corticosteroid and taken as required (PRN) short acting beta 2 agonist therapy only
Unchanged dose of inhaled corticosteroid for 3 months prior to Day 0 and no expected need for change in dose during study
Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% predicted at Screening (Baseline)
18-60 years
General Practitioner diagnosis of asthma of 1 year's minimum duration (with respect to Day 0)

Show all 12Show fewer

No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
12-lead electrocardiogram with no clinical significant abnormality
Clinical chemistry hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
A negative screen for drugs of abuse and alcohol
Body weight between 50-120 kg
Subjects aged between 18-40 years inclusive must have body mass index (BMI) 18-32 kilogram per square meter (kg/m^2) inclusive. Subjects aged between 41-60 years must have BMI between 18-30 kg/m^2 inclusive.

Who cannot join

Active concomitant disease, with exception of eczema
Expected onset of seasonal allergy before the administration of the last dose of study medication
History of severe exacerbation within 3 years of Day 0
Recorded use of inhaled short acting beta 2 agonist medication for symptoms within 14 days of Day 0 of: More than 6 doses per day on any 1 day or more than 3 doses per day on 6 or more days
Any medication other than: inhaled short-acting beta 2 agonist, inhaled corticosteroids, topic eczema treatments (with the exception of fluorinated corticosteroid, dermatological preparations which are not permitted), hormone replacement therapy, vitamin preparation/food supplements, occasional use of proton pump inhibitors, ranitidine, cimetidine, antacids or over-the-counter analgesics
Treatment within 6 months of Day 0 with any of the following: methylxanthines, inhaled cromones, leukotriene modifiers, anti- immunoglobulin E (IgE), anticholinergics, ketotifen, oral short acting B2 agonists, long-acting B2 agonists, oral or injected corticosteroids

Show all 18Show fewer

Treatment of atopic symptoms, other than eczema, within 4 weeks of Day 0
History of medication that might carry-over effects into the study
Previously received monoclonal antibody, or a similar related protein, that might sensitize to CAT-354
Participation in another study within three months of the start of the study or 5 half lives of the previously administered investigational medicinal product (IMP), whichever is longer
Lower respiratory tract infection within 4 weeks of Day-14
Any acute illness in the two weeks before Day 0
Current smokers, those who have smoked in previous year, and those with smoking history of greater than or equal to 10 pack years
Considered by the investigator to be at risk of transmitting, through blood, the agents responsible for infectious diseases
Blood donation (550 ml) in the previous 2 months
Excessive intake of alcohol (more than 21 units a week for females or 28 units a week for males)
The subject's general practitioner has suggested a reason the subject should not participate in the study
The Investigator considers the subject should not take part for any reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Chiltern International Limited
Slough, Berkshire, SL1 2AD

Other trials in United Kingdom

About this study

Official title: A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma

The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.

Read the detailed description

This study is a randomized, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and randomly assigned within dose group to either CAT-354 or placebo. Doses of the assigned treatment will be administered on three occasions 28 days apart. Follow up for pharmacokinetic blood sampling and safety will continue to Day 147 post-first dose (91 days post-third dose).

Conditions: Moderate Asthma
Being tested: CAT-354 1mg/kg, CAT-354 5 mg/kg, CAT-354 10mg/kg, Placebo
Keywords: Asthma, CAT-354, Tralokinumab
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CAT-354 1mg/kgBiological
Also called Tralokinumab
CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kgBiological
Also called Tralokinumab
CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 10mg/kgBiological
Also called Tralokinumab
CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
PlaceboOther
Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.

Study groups in NCT00974675
Study group	Role	What they receive
CAT-354 1 mg/kg	Experimental	CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Receives: Biological: CAT-354 1mg/kg
CAT-354 5 mg/kg	Experimental	CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Receives: Biological: CAT-354 5 mg/kg
CAT-354 10mg/kg	Experimental	CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. Receives: Biological: CAT-354 10mg/kg
Placebo	Placebo comparator	Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose
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).
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Clearance (CL) for CAT-354 After First Dose
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.
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Volume of Distribution (Vd) for CAT-354 After First Dose
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.
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose
Measured: Pre-dose on Day 28
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose
Measured: Pre-dose on Day 56
Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose
Measured: Day 84
Accumulation Ratio (R0) for CAT-354
Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.
Measured: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84

Secondary outcomes (1)

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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 to pre-treatment state.
Measured: Day 0 to Day 147

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 20063 Aug 2007

First posted10 Sep 2009 (estimated)
Study start29 Sep 2006
Primary completion3 Aug 2007
Study completion3 Aug 2007

Why it stopped: Study recruitment was terminated before the planned number of subjects was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Moderate AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00974675
Sponsor's protocol ID: CAT-354-0602
Other IDs: 2006-003199-36
Status last verified: Mar 2017
First submitted: 8 Sep 2009
Last updated: 2 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Singh D, Kane B, Molfino NA, Faggioni R, Roskos L, Woodcock A. A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. BMC Pulm Med. 2010 Jan 8;10:3. doi: 10.1186/1471-2466-10-3.
PubMed 20064211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma
ClinicalTrials.gov ID: NCT00974675
Acronym / sponsor ID: CAT-354-0602
Conditions: Moderate Asthma
Keywords: Asthma, CAT-354, Tralokinumab
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study recruitment was terminated before the planned number of subjects was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.
Enrolment: 23 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 29 Sep 2006 (actual)
Primary completion: 3 Aug 2007 (actual)
Study completion: 3 Aug 2007 (actual)
First posted: 10 Sep 2009 (estimated)
Results: Posted 2 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
CAT-354 1 mg/kg	Experimental	Biological: CAT-354 1mg/kgCAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 5 mg/kg	Experimental	Biological: CAT-354 5 mg/kgCAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
CAT-354 10mg/kg	Experimental	Biological: CAT-354 10mg/kgCAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
Placebo	Placebo comparator	Other: PlaceboPlacebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Males or infertile females
Subjects with asthma, well controlled on inhaled corticosteroid and taken as required (PRN) short acting beta 2 agonist therapy only
Unchanged dose of inhaled corticosteroid for 3 months prior to Day 0 and no expected need for change in dose during study
Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% predicted at Screening (Baseline)
18-60 years

Key exclusion criteria (18 listed)

Active concomitant disease, with exception of eczema
Expected onset of seasonal allergy before the administration of the last dose of study medication
History of severe exacerbation within 3 years of Day 0
Recorded use of inhaled short acting beta 2 agonist medication for symptoms within 14 days of Day 0 of: More than 6 doses per day on any 1 day or more than 3 doses per day on 6 or more days
Any medication other than: inhaled short-acting beta 2 agonist, inhaled corticosteroids, topic eczema treatments (with the exception of fluorinated corticosteroid, dermatological preparations which are not permitted), hormone replacement therapy, vitamin preparation/food supplements, occasional use of proton pump inhibitors, ranitidine, cimetidine, antacids or over-the-counter analgesics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CAT-354 1mg/kgAlso: TralokinumabCAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological	CAT-354 1 mg/kg
CAT-354 5 mg/kgAlso: TralokinumabCAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological	CAT-354 5 mg/kg
CAT-354 10mg/kgAlso: TralokinumabCAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.	Biological	CAT-354 10mg/kg
PlaceboPlacebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.	Other	Placebo

Primary outcome

Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35
Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
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).
Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.
Clearance (CL) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
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.
Volume of Distribution (Vd) for CAT-354 After First Dose
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21
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.
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose
Time frame: Pre-dose on Day 28
Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose
Time frame: Pre-dose on Day 56
Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose
Time frame: Day 84
Accumulation Ratio (R0) for CAT-354
Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84
Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.

1 secondary outcome

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 0 to Day 147

Results and safety

Results posted to the registry on 2 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAT-354 1 mg/kg	8	6
CAT-354 5 mg/kg	8	7
CAT-354 10 mg/kg	3	1
Placebo	4	2

Primary outcome: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose

Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21. Mean (Standard Deviation). Unit: microgram/milliliter (mcg/mL)

Measure	CAT-354 1 mg/kg n = 8	CAT-354 5 mg/kg n = 8	CAT-354 10 mg/kg n = 3
Value	30.3 (5.18)	156.8 (34.55)	306.3 (31.39)

Population analysed: Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.

Primary outcome: Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose

Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35. Mean (Standard Deviation). Unit: mcg/mL

Measure	CAT-354 1 mg/kg n = 7	CAT-354 5 mg/kg n = 7	CAT-354 10 mg/kg n = 1
Value	35.0 (6.81)	161.0 (32.81)	298.0 (NA)

Population analysed: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Primary outcome: Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose

Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147. Mean (Standard Deviation). Unit: mcg/mL

Measure	CAT-354 1 mg/kg n = 6	CAT-354 5 mg/kg n = 7	CAT-354 10 mg/kg n = 1
Value	41.1 (4.77)	178.7 (25.41)	393.0 (NA)

Primary outcome: Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose

Time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21. Mean (Standard Deviation). Unit: (mcg*day)/mL

Measure	CAT-354 1 mg/kg n = 8	CAT-354 5 mg/kg n = 8	CAT-354 10 mg/kg n = 3
Value	299.6 (42.03)	1691.3 (302.70)	3106.3 (719.25)

Population analysed: PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 0 to 147. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg/kg	0 of 8 (0%)	8 of 8 (100%)	Not reported
5 mg/kg	1 of 8 (12.5%)	8 of 8 (100%)	Not reported
10 mg/kg	0 of 3 (0%)	3 of 3 (100%)	Not reported
Placebo	0 of 4 (0%)	4 of 4 (100%)	Not reported

Limitations and caveats (from the sponsor): Recruitment to the study was terminated before the planned number of participants was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20064211Singh D, Kane B, Molfino NA, Faggioni R, Roskos L, Woodcock A. A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. BMC Pulm Med. 2010 Jan 8;10:3. doi: 10.1186/1471-2466-10-3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MedImmune LLC study director

MedImmune LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAT-354 1mg/kg, CAT-354 5 mg/kg and CAT-354 10mg/kg in people with Moderate Asthma, run by MedImmune LLC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (time frame: Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.