HealthyPhase 1NCT01093040
A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects
A Phase 1 study testing CAT-354 and CAT 354 in people with Healthy, run by MedImmune LLC at 1 site in United States.
Trial summary
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CAT-354 and CAT 354
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged 20 through 55 years at the time of screening
- Signed and dated written informed consent is obtained prior to any study related procedure taking place
- No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- 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
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- The following reproductive criteria apply:
- Females(of child bearing potential) must have a negative pregnancy test prior to the dose of investigational product and, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, or at least 2 years postmenopausal, or practices abstinence; must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted hormonal contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 21 days prior to randomization, and must agree to continue using such precautions until 3 months after dosing with the investigational product; cessation of birth control after this point should be discussed with a responsible physician. A negative pregnancy test is required both at screening and prior to dosing.
- Males, unless surgically sterile, must use two effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from 21 days prior to randomization until 3 months after dosing with the investigational product.
- Japanese subjects. To be considered as 'Japanese', both of the subject's parents, and both sets of grandparents, must be Japanese. The subject must have been born in Japan, have a valid Japanese passport, and must not have lived outside Japan for more than 5 years.
- Body mass index (BMI) between 18 and 27 kg/m 2 , inclusive
- Able to comply with the requirements of the protocol
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354 or to any component of the investigational product formulation
- History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection
- Any acute illness in the 14 days before Day 1 (Visit 2)
- Use of any medication (prescription or OTC) excluding hormonal contraception within 14 days (or 5-half lives, whichever is longer) of Day 1 dosing
- Involvement in another study of investigational medicinal product; within 2 months of the start of this study (Day 1) for small molecules, within 3 months of the start of this study for antibodies, or 5 half lives of the previously administered investigational product, whichever is the longer
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- Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- Subjects with immunodeficiency disorders
- Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Any active concomitant disease including psychological disorders
- Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first-degree relative of the aforementioned.
- Any factor which, in the opinion of the Investigator, would be associated with poor adherence to the protocol
- Female subjects: lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Single-blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CAT-354 Following Subcutaneous Administration in Healthy Male and Female Japanese Subjects
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
Read the detailed description
The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.
- Conditions
- Healthy
- Being tested
- CAT-354, CAT 354
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-354Drug
150 mg CAT-354 or placebo given SC on Day 1
CAT-354Drug
300 mg CAT-354 or placebo given SC on Day 1
CAT 354Drug
600 mg CAT-354 or placebo given SC on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | CAT-354 will be administered by SC injection Receives: Drug: CAT-354 |
| Cohort 2 | Experimental | CAT-354 will be administered by SC injection Receives: Drug: CAT-354 |
| Cohort 3 | Experimental | CAT-354 will be administered by SC injection Receives: Drug: CAT 354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
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.
Measured: Study Day 71
Secondary outcomes (1)
Immunogenicity
The PK variables and IM variables of CAT-354 in healthy Japanese subjects will be evaluated. The incidence rate of positive serum antibodies to CAT-354 will be reported by treatment group.
Measured: Study Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Katsuro Yagawa, M.D., Study director, Astra Zeneca K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093040
- Sponsor's protocol ID
- MI-CP224
- Status last verified
- Aug 2012
- First submitted
- 19 Mar 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Single-blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CAT-354 Following Subcutaneous Administration in Healthy Male and Female Japanese Subjects
- ClinicalTrials.gov ID
- NCT01093040
- Acronym / sponsor ID
- MI-CP224
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd, AstraZeneca
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
Detailed description
The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CAT-354CAT-354 will be administered by SC injection |
| Cohort 2 | Experimental | Drug: CAT-354CAT-354 will be administered by SC injection |
| Cohort 3 | Experimental | Drug: CAT 354CAT-354 will be administered by SC injection |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female subjects aged 20 through 55 years at the time of screening
- Signed and dated written informed consent is obtained prior to any study related procedure taking place
- No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
Key exclusion criteria (13 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354 or to any component of the investigational product formulation
- History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection
- Any acute illness in the 14 days before Day 1 (Visit 2)
- Use of any medication (prescription or OTC) excluding hormonal contraception within 14 days (or 5-half lives, whichever is longer) of Day 1 dosing
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-354150 mg CAT-354 or placebo given SC on Day 1 | Drug | Cohort 1 |
| CAT-354300 mg CAT-354 or placebo given SC on Day 1 | Drug | Cohort 2 |
| CAT 354600 mg CAT-354 or placebo given SC on Day 1 | Drug | Cohort 3 |
Primary outcome
Safety
Time frame: Study Day 71
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.
1 secondary outcome
Immunogenicity
Time frame: Study Day 71
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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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.
Katsuro Yagawa, M.D. study director
Astra Zeneca K.K.
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 and CAT 354 in people with Healthy, run by MedImmune LLC at 1 site in United States.
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 13 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: finished, as of the sponsor's last update on 30 Aug 2012. 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 States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: Study Day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2012.