Healthy VolunteersPhase 1NCT03375138
A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes
A Phase 1 study testing belatacept in people with Healthy Volunteers, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- belatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2017to 2 Apr 2019
- 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
- Signed informed consent form.
- Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
- Weight between 60.0 to 100.0 kg, inclusive.
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
- Women must not be breastfeeding.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.
Who cannot join
- Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
- History of shingles (herpes zoster).
- Personal or strong family history of cancer.
- Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
- Any known or suspected autoimmune disorder.
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Austin Clinic
Austin, Texas, 78744
Covance, Inc.
Dallas, Texas, 75247
About this study
Official title: A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants
This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.
- Conditions
- Healthy Volunteers
- Being tested
- belatacept
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
belataceptDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Process E PPQ belatacept | Experimental | 10 mg/kg, single dose by intravenous (IV) infusion. Receives: Drug: belatacept |
| Process C belatacept | Experimental | 10 mg/kg, single dose by intravenous (IV) infusion. Receives: Drug: belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).
Measured by plasma concentration.
Measured: Up to day 57
Maximum observed serum concentration (Cmax).
Measured by plasma concentration.
Measured: Up to day 57
Secondary outcomes (7)
Incidence of non-serious Adverse Events (AEs).
Safety and tolerability as measured by incidence of non-serious AEs.
Measured: Up to 71 days.
Incidence of Serious Adverse Events (SAEs).
Safety and tolerability as measured by incidence of SAEs.
Measured: Up to 71 days.
Incidence of Adverse Events (AEs) leading to discontinuation.
Safety and tolerability as measured by incidence of AEs leading to discontinuation.
Measured: Up to 71 days.
Number of participants with vital sign abnormalities.
Measured: Up to 71 days.
Number of participants with physical examination abnormalities.
Measured: Up to 71 days.
Number of participants with clinical laboratory abnormalities.
Measured: Up to 71 days.
Number of participants with electrocardiogram (ECG) abnormalities.
Measured: Up to 71 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start4 Dec 2017
- Primary completion8 May 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375138
- Sponsor's protocol ID
- IM103-399
- Status last verified
- Jul 2019
- First submitted
- 13 Dec 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants
- ClinicalTrials.gov ID
- NCT03375138
- Acronym / sponsor ID
- IM103-399
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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 study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Process E PPQ belatacept | Experimental | Drug: belatacept10 mg/kg, single dose by intravenous (IV) infusion. |
| Process C belatacept | Experimental | Drug: belatacept10 mg/kg, single dose by intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent form.
- Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
- Weight between 60.0 to 100.0 kg, inclusive.
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
Key exclusion criteria (6 listed)
- Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
- History of shingles (herpes zoster).
- Personal or strong family history of cancer.
- Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
- Any known or suspected autoimmune disorder.
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 |
|---|---|---|
| belataceptSpecified dose on specified days | Drug | Process C belatacept, Process E PPQ belatacept |
Primary outcome
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).
Time frame: Up to day 57
Measured by plasma concentration.
Maximum observed serum concentration (Cmax).
Time frame: Up to day 57
Measured by plasma concentration.
7 secondary outcomes
Incidence of non-serious Adverse Events (AEs).
Time frame: Up to 71 days.
Incidence of Serious Adverse Events (SAEs).
Time frame: Up to 71 days.
Incidence of Adverse Events (AEs) leading to discontinuation.
Time frame: Up to 71 days.
Number of participants with vital sign abnormalities.
Time frame: Up to 71 days.
Number of participants with physical examination abnormalities.
Time frame: Up to 71 days.
Number of participants with clinical laboratory abnormalities.
Time frame: Up to 71 days.
Number of participants with electrocardiogram (ECG) abnormalities.
Time frame: Up to 71 days.
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 24 Jul 2019.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial InformationLink 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 belatacept in people with Healthy Volunteers, run by Bristol-Myers Squibb 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 8 inclusion and 6 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 24 Jul 2019. 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?
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?
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)). (time frame: Up to day 57). The study lists 2 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 24 Jul 2019.