PharmacokineticsPhase 1NCT02673567
To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125
A Phase 1 study testing TEV-48125 - 1, TEV-48125 - 2 and TEV-48125 - 3 in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- TEV-48125 - 1, TEV-48125 - 2 and TEV-48125 - 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2016to 10 Feb 2017
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a man or woman, 18 to 55 years of age, inclusive
- The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
- The subjects must be in a good health at screening and check-in
- Additional inclusion criteria for Japanese subjects:
- Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
- Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
Show all 10Show fewer
- Subject has been living outside of Japan for no more than 10 years
- Additional inclusion criteria for Caucasian subjects:
- The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.
- Additional criteria apply, please contact the investigator for more information
Who cannot join
- The subject is a woman who is pregnant or lactating
- The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)
- The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment
- Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing
- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
United States1 site
Teva Investigational Site 13529
Glendale, California, 91206
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.
- Conditions
- Pharmacokinetics
- Being tested
- TEV-48125 - 1, TEV-48125 - 2, TEV-48125 - 3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-48125 - 1Drug
Also called monoclonal antibody
Subcutaneous administration Dose Regimen 1
TEV-48125 - 2Drug
Also called monoclonal antibody
Subcutaneous administration Dose Regimen 2
TEV-48125 - 3Drug
Also called monoclonal antibody
Subcutaneous administration Dose Regimen 3
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| TEV-48125 - 1 | Experimental | Dose Regimen 1 Receives: Drug: TEV-48125 - 1 |
| TEV-48125 - 2 | Experimental | Dose Regimen 2 Receives: Drug: TEV-48125 - 2 |
| TEV-48125 - 3 | Experimental | Dose Regimen 3 Receives: Drug: TEV-48125 - 3 |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma drug concentration (Cmax)
Measured: 33 weeks
Time to maximum observed plasma drug concentration (tmax)
Measured: 33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
Measured: 33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
Measured: 33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
Measured: 33 weeks
Percentage extrapolated AUC (%AUCext)
Measured: 33 weeks
Apparent serum terminal elimination rate constant (λz)
Measured: 33 weeks
Apparent total body clearance (CL/F)
Measured: 33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: 33 weeks
Apparent serum terminal elimination half-life (t½)
Measured: 33 weeks
Secondary outcomes (3)
Percentage of Participants with Adverse Events
Measured: 33 weeks
Tolerability- Percentage of participants who fail to complete the study
Measured: 33 weeks
Percentage of participants who fail to complete the study due to adverse events
Measured: 33 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start31 Mar 2016
- Primary completion16 Dec 2016
- Study completion10 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673567
- Sponsor's protocol ID
- TV48125-PK-10078
- Status last verified
- Dec 2021
- First submitted
- 26 Jan 2016
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects
- ClinicalTrials.gov ID
- NCT02673567
- Acronym / sponsor ID
- TV48125-PK-10078
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 4 Feb 2016 (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.
This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TEV-48125 - 1 | Experimental | Drug: TEV-48125 - 1Dose Regimen 1 |
| TEV-48125 - 2 | Experimental | Drug: TEV-48125 - 2Dose Regimen 2 |
| TEV-48125 - 3 | Experimental | Drug: TEV-48125 - 3Dose Regimen 3 |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is a man or woman, 18 to 55 years of age, inclusive
- The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
- The subjects must be in a good health at screening and check-in
- Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
- Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
Key exclusion criteria (5 listed)
- The subject is a woman who is pregnant or lactating
- The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)
- The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment
- Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before 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 |
|---|---|---|
| TEV-48125 - 1Also: monoclonal antibodySubcutaneous administration Dose Regimen 1 | Drug | TEV-48125 - 1 |
| TEV-48125 - 2Also: monoclonal antibodySubcutaneous administration Dose Regimen 2 | Drug | TEV-48125 - 2 |
| TEV-48125 - 3Also: monoclonal antibodySubcutaneous administration Dose Regimen 3 | Drug | TEV-48125 - 3 |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
Maximum observed plasma drug concentration (Cmax)
Time frame: 33 weeks
Time to maximum observed plasma drug concentration (tmax)
Time frame: 33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
Time frame: 33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
Time frame: 33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time frame: 33 weeks
Percentage extrapolated AUC (%AUCext)
Time frame: 33 weeks
Apparent serum terminal elimination rate constant (λz)
Time frame: 33 weeks
Apparent total body clearance (CL/F)
Time frame: 33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: 33 weeks
Apparent serum terminal elimination half-life (t½)
Time frame: 33 weeks
3 secondary outcomes
Percentage of Participants with Adverse Events
Time frame: 33 weeks
Tolerability- Percentage of participants who fail to complete the study
Time frame: 33 weeks
Percentage of participants who fail to complete the study due to adverse events
Time frame: 33 Weeks
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 13 Dec 2021.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
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 TEV-48125 - 1, TEV-48125 - 2 and TEV-48125 - 3 in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. 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 10 inclusion and 5 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 13 Dec 2021. 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. 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?
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?
Maximum observed plasma drug concentration (Cmax) (time frame: 33 weeks). The study lists 10 primary outcomes in all. 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 13 Dec 2021.