Healthy Volunteers
Conditions
Keywords
Healthy volunteers
Brief 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. 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.
Interventions
DRUGbelatacept
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)). | Up to day 57 | Measured by plasma concentration. |
| Maximum observed serum concentration (Cmax). | Up to day 57 | Measured by plasma concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) leading to discontinuation. | Up to 71 days. | Safety and tolerability as measured by incidence of AEs leading to discontinuation. |
| Number of participants with vital sign abnormalities. | Up to 71 days. | — |
| Incidence of non-serious Adverse Events (AEs). | Up to 71 days. | Safety and tolerability as measured by incidence of non-serious AEs. |
| Number of participants with clinical laboratory abnormalities. | Up to 71 days. | — |
| Number of participants with electrocardiogram (ECG) abnormalities. | Up to 71 days. | — |
| Number of participants with physical examination abnormalities. | Up to 71 days. | — |
| Incidence of Serious Adverse Events (SAEs). | Up to 71 days. | Safety and tolerability as measured by incidence of SAEs. |
Countries
United States
Outcome results
None listed