AzTrials
AzTrials

AsthmaPhase 1NCT00638989

A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

A Phase 1 study testing CAT-354 150 mg (intravenous), CAT-354 150 mg (subcutaneous) and CAT-354 300 mg (subcutaneous) in people with Asthma and Healthy, run by MedImmune LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration. Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Asthma, Healthy
What is being tested?
CAT-354 150 mg (intravenous), CAT-354 150 mg (subcutaneous) and CAT-354 300 mg (subcutaneous)
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
11 Apr 2008to 7 Jun 2008
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 19 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed and dated written informed consent is obtained prior to any study related procedure taking place
  • Males, aged 19-55 years
  • 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
Show all 9Show fewer
  • Body mass index (BMI) between 18-30 kilogram per square meter (kg/m^2), inclusive
  • No other clinically significant abnormality on history and clinical examination
  • Able to comply with the requirements of the protocol.

Who cannot join

  • Any active concomitant disease including psychological disorders
  • History of medication that might carry over effects into study
  • Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354
  • Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given
  • Any acute illness in the 2 weeks before Day 0 (Visit 2)
  • Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
Show all 11Show fewer
  • 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 jeopardize the evaluation or safety or be associated with poor adherence to the protocol
  • The subject's primary care physician recommends the subject should not take part in the study
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MDS Pharma Services (US) Inc.

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration

To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.

Read the detailed description

To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.

Conditions
Asthma, Healthy
Being tested
CAT-354 150 mg (intravenous), CAT-354 150 mg (subcutaneous), CAT-354 300 mg (subcutaneous)
Keywords
Asthma, CAT-354, Tralokinumab, Healthy
Medical subject headings
Asthma

What participants receive

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

  • CAT-354 150 mg (intravenous)Biological

    Also called Tralokinumab

    A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.

  • CAT-354 150 mg (subcutaneous)Biological

    Also called Tralokinumab

    A single dose of CAT-354 150 mg injection subcutaneously on Day 0.

  • CAT-354 300 mg (subcutaneous)Biological

    Also called Tralokinumab

    A single dose of CAT-354 300 mg injection subcutaneously on Day 0.

Study groups in NCT00638989
Study groupRoleWhat they receive
CAT-354 150 mg (intravenous)ExperimentalA single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
Receives: Biological: CAT-354 150 mg (intravenous)
CAT-354 150 mg (subcutaneous)ExperimentalA single dose of CAT-354 150 mg injection subcutaneously on Day 0.
Receives: Biological: CAT-354 150 mg (subcutaneous)
CAT-354 300 mg (subcutaneous)ExperimentalA single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Receives: Biological: CAT-354 300 mg (subcutaneous)

What is being measured

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

  1. Absolute Bioavailability of CAT-354 After Subcutaneous Dose

    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).

    Measured: 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

Secondary outcomes (12)

  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 administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.

    Measured: Day 0 to 56

  2. Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit

    Measured: Day 0 and Day 56

  3. Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])

    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).

    Measured: 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

  4. Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])

    Measured: 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

  5. Dose Normalized Area Under the Concentration-time Curve From 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). (AUC [0 - infinity]) was normalized by CAT-354 dose.

    Measured: 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

  6. Maximum Observed Serum Concentration (Cmax)

    Measured: 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

  7. Dose Normalized Maximum Observed Concentration (Cmax/Dose)

    Measured: 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

  8. Time to Reach Maximum Observed Serum Concentration (Tmax)

    Measured: 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

  9. Terminal Phase Elimination Half Life (t1/2)

    Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.

    Measured: 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

  10. Apparent Systemic Clearance (CL/F) After Subcutaneous Dose

    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).

    Measured: 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

  11. Apparent Systemic Clearance (CL/F) After Intravenous Dose

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

    Measured: 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

  12. Volume of Distribution at Steady State (Vss) After Intravenous Infusion

    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 at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM[Infinity] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).

    Measured: Predose, end of infusion, 30 minutes, at 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

Timeline

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

  1. First posted19 Mar 2008 (estimated)
  2. Study start11 Apr 2008
  3. Primary completion7 Jun 2008
  4. Study completion7 Jun 2008

Resources

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
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00638989
Sponsor's protocol ID
CAT-354-0703
Status last verified
Mar 2017
First submitted
12 Mar 2008
Last updated
4 May 2017
Data monitoring committee
No

Publications

  • Oh CK, Faggioni R, Jin F, Roskos LK, Wang B, Birrell C, Wilson R, Molfino NA. An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males. Br J Clin Pharmacol. 2010 Jun;69(6):645-55. doi: 10.1111/j.1365-2125.2010.03647.x.

    PubMed 20565456

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAT-354 150 mg (intravenous), CAT-354 150 mg (subcutaneous) and CAT-354 300 mg (subcutaneous) in people with Asthma and 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 9 inclusion and 11 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 4 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 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?

Yes. Results are posted in the registry (first posted 4 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?

Absolute Bioavailability of CAT-354 After Subcutaneous Dose (time frame: 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). 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 NCT00638989, 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 4 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in