AsthmaPhase 1NCT02085473
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
A Phase 1 study testing Tralokinumab 300 mg in people with Asthma and Healthy Subjects or Volunteers, run by MedImmune LLC at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Healthy Subjects or Volunteers
- What is being tested?
- Tralokinumab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2014to 10 Jul 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females ages 19-65 years
- Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)
- No clinically significant abnormality
- Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
- Negative alcohol and drug screens
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.
Who cannot join
- Concurrent enrollment in another clinical study where the subject is receiving an investigational product
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
- Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
- History of thrombocytopenia or bleeding disorder or use of anticoagulants
- History of any immunodeficiency disorder or use of immunosuppressive medication.
Show all 10Show fewer
- History of a clinically significant infection
- History of cancer
- Positive Hepatitis B or C
- Positive HIV
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Research Site
Lincoln, Nebraska, 68502
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Tralokinumab When Delivered as a 2 mL Injection at Different Flow Rates to Healthy Volunteers
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
Read the detailed description
This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.
- Conditions
- Asthma, Healthy Subjects or Volunteers
- Being tested
- Tralokinumab 300 mg
- Keywords
- Asthma, Healthy Subjects or Volunteers, Tralokinumab, CAT-354
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tralokinumab 300 mgBiological
Also called CAT-354
Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min. Receives: Biological: Tralokinumab 300 mg |
| Cohort 2 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min. Receives: Biological: Tralokinumab 300 mg |
| Cohort 3 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min. Receives: Biological: Tralokinumab 300 mg |
| Cohort 4 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min. Receives: Biological: Tralokinumab 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL.
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Maximum Observed Serum Concentration (Cmax)
The Cmax is the maximum observed serum concentration of tralokinumab.
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Time to Maximum Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Terminal Elimination Half-life (t1/2)
Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
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: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Apparent Terminal-Phase Volume of Distribution (Vz/F)
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.
Measured: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Secondary outcomes (7)
Local Injection-Site Pain and Injection-Site Pruritus
Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA.
Measured: During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus
Number of Participants Reporting Local Injection-Site Reactions
The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor.
Measured: 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection
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 and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: From start of study drug administration up to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 1 to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 1 to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 1 to Day 57
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples.
Measured: Pre-dose on Day 1 and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study start19 Mar 2014
- Primary completion10 Jul 2014
- Study completion10 Jul 2014
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Cook, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085473
- Sponsor's protocol ID
- D2210C00011
- Status last verified
- Dec 2018
- First submitted
- 11 Mar 2014
- Last updated
- 31 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jain M, Doughty D, Clawson C, Li X, White N, Agoram B, van der Merwe R. Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates . Int J Clin Pharmacol Ther. 2017 Jul;55(7):606-620. doi: 10.5414/CP203023.
PubMed 28590244
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Tralokinumab When Delivered as a 2 mL Injection at Different Flow Rates to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02085473
- Acronym / sponsor ID
- D2210C00011
- Conditions
- Asthma, Healthy Subjects or Volunteers
- Keywords
- Asthma, Healthy Subjects or Volunteers, Tralokinumab, CAT-354
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 10 Jul 2014 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
Detailed description
This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Biological: Tralokinumab 300 mgParticipants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min. |
| Cohort 2 | Experimental | Biological: Tralokinumab 300 mgParticipants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min. |
| Cohort 3 | Experimental | Biological: Tralokinumab 300 mgParticipants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min. |
| Cohort 4 | Experimental | Biological: Tralokinumab 300 mgParticipants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males and females ages 19-65 years
- Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)
- No clinically significant abnormality
- Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
- Negative alcohol and drug screens
Key exclusion criteria (10 listed)
- Concurrent enrollment in another clinical study where the subject is receiving an investigational product
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
- Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
- History of thrombocytopenia or bleeding disorder or use of anticoagulants
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 |
|---|---|---|
| Tralokinumab 300 mgAlso: CAT-354Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL.
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
The Cmax is the maximum observed serum concentration of tralokinumab.
Time to Maximum Concentration (Tmax)
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.
Terminal Elimination Half-life (t1/2)
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose
Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-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).
Apparent Terminal-Phase Volume of Distribution (Vz/F)
Time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-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.
7 secondary outcomes
Local Injection-Site Pain and Injection-Site Pruritus
Time frame: During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus
Number of Participants Reporting Local Injection-Site Reactions
Time frame: 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From start of study drug administration up to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination
Time frame: Day 1 to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs
Time frame: Day 1 to Day 57
Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters
Time frame: Day 1 to Day 57
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Time frame: Pre-dose on Day 1 and Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28590244Jain M, Doughty D, Clawson C, Li X, White N, Agoram B, van der Merwe R. Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates . Int J Clin Pharmacol Ther. 2017 Jul;55(7):606-620. doi: 10.5414/CP203023.
- Redacted ProtocolLink provided by the sponsor.
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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.
Barbara Cook, MD principal investigator
Celerion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tralokinumab 300 mg in people with Asthma and Healthy Subjects or Volunteers, run by MedImmune LLC at 2 sites 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 7 inclusion and 10 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 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 23 Nov 2018). 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?
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) (time frame: Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose). The study lists 7 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 NCT02085473, 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 31 Dec 2018.