A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 12/30/2018 |
| Start Date: | December 4, 2017 |
| End Date: | January 15, 2019 |
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.
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.
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/exclusion criteria could apply.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials