The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
rheumatoid arthritis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate pharmacokinetic similarity of DRL_AB versus RP and RMP and
between the RP and the RMP after administration of a 750 mg
single IV dose.
Secondary outcome
To assess the safety and tolerability of DRL_AB, RP and RMP.
To assess the immunogenicity of DRL_AB, RP and RMP.
Background summary
DRL_AB is a new biological product that may potentially be used for the
treatment of rheumatoid arthritis (RA). RA is characterized by long-lasting
inflammation associated with pain, stiffness, swelling, and sometimes
destruction of joints. This results in reduced mobility. RA is an autoimmune
disease, which means it is a type of disease where the body*s own immune cells
attack the body. DRL_AB is a protein that inhibits the activation of immune
cells and could thereby potentially help in the treatment of RA.
Orencia® is a drug that is already approved in Europe and the US for the
treatment of RA. The study drug remains in the body for a long time. The
half-life, that is the time it takes for the amount of the study drug in the
blood to be halved, is approximately 17 days. This is the reason the volunteers
have to return to the research center for visits over a long period.
Study objective
The sponsor is developing a biological product (DRL_AB) similar to the approved
medicine Orencia®. As part of medical-scientific studies to confirm the
similarity of the biological products, the Sponsor wants to compare DRL_AB with
EU-approved Orencia® and US-licensed Orencia®. All these 3 biological products
have the same active ingredient, called abatacept.
The purpose of this study is to compare how quickly and to what extent DRL_AB,
EU-approved Orencia®, and US-licensed Orencia® are available, broken down, and
eliminated from the body. In addition, the study will assess the safety and
tolerability of DRL_AB and both Orencia® products, and how the body responds to
each product.
This is the first study where DRL_AB will be given to humans. It has been
extensively tested in the laboratory.Orencia® is no new product; it is already
being used by patients for the treatment of rheumatoid arthritis. Please note
that when the term *study drug* is used in this document, it can mean DRL_AB,
EU-approved Orencia® or US-licensed Orencia®.
Study design
The study lasts a maximum of 16 weeks from the inspection to the follow-up
check.
For the research it is necessary to stay in the research center for 6 days (5
nights). After this there are 10 more visits to the research center. These
short visits are on Days 6, 8, 10, 15, 22, 29, 43, 57, 71 and 85. Day 1 is the
day one receives the study drug. One is expected at the study center on Day -1,
which is the day prior to study drug administration. One must be at the
research center between 9:30 AM and 2:00 PM. Before coming to the research
center, you will be informed about the exact
time. The volunteers leave the study center on Day 5 of the study.
You will receive DRL_AB or EU-approved Orencia® or US-licensed Orencia® as an
intravenous infusion (solution of the study drug administered directly into a
blood vessel in your arm). The infusion will take 30 minutes and approximately
30 ml of study solution will be administered after it has been diluted with
0.9% sodium chloride
Intervention
Not applicable.
Study burden and risks
Blood draw
Blood draws may hurt or cause bruising. Using an indwelling cannula can
sometimes cause inflammation, swelling, hardening of the artery, or blood
clotting and bleeding around the puncture site. In some individuals, a blood
draw can sometimes cause paleness, nausea, sweating, slow heart rate, or drop
in blood pressure with dizziness or fainting.
All in all, we take approximately 181.5 milliliters (ml) of blood from the
inspection to the follow-up. This amount does not cause any problems in adults.
If the investigator deems this necessary to ensure the safety of the
participant, additional samples may be taken for any additional testing. If
this happens, the total amount of blood drawn may be more than the amount
indicated above.
ECG
To make a heart film, electrodes are placed on the arms, chest and legs.
Prolonged use of these electrodes may cause skin irritation.
Coronavirus test
Samples for the coronavirus test will be taken with cotton swabs at the back of
the nose and throat. Collecting the samples only takes a few seconds, but can
cause discomfort and discomfort. Taking a sample from the back of the throat
may result in gagging. When the sample is taken at the back of the nose, you
may experience a stinging sensation and the eyes may water.
Survey No. 47, Bachupally Village, Bachupally Mandal, 47
Telangana 500 090
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Survey No. 47, Bachupally Village, Bachupally Mandal, 47
Telangana 500 090
IN
Listed location countries
Age
Inclusion criteria
1. Healthy Male volunteers, 18 to 50 years of age (both age inclusive) at the
time of signing informed consent.
2. In general, good health as determined by a qualified physician based on a
comprehensive medical history, physical examination including vital signs,
laboratory haematology, clinical chemistry, urinalysis and 12-lead
electrocardiogram (ECG) before randomization.
3. Body mass index between 18.5-30.0 kg/m2 (both inclusive) and body weight of
60.0 - 100.0 kg (both inclusive).
4. Screening parameters (vital signs, physical examination, clinical laboratory
tests, 12-lead ECG, thyroid function) within the normal range or outside the
normal range then assessed as clinically non-significant by the Investigator
(unless the value constitutes an explicit exclusion criterion).
Exclusion criteria
1. Positive test result for Quantiferon- TB Gold test, syphilis, hepatitis B,
hepatitis C, or HIV-1 or 2.
2. Vaccination with live vaccines within 3 months prior to Screening or
intention to receive live vaccines during the trial or up to 3 months after the
administration of the study drug. Non-live vaccines should be administered at
least a week before the study drug administration to
avoid interference with immunization.
3. Any prior exposure to abatacept or to any other agent directly acting on
CTLA4 or the CD28-CD80 co-stimulation pathway (eg. pembrolizumab (Keytruda),
ipilimumab (Yervoy), nivolumab (Opdivo) and atezolizumab (Tecentriq)) including
investigational products.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-000926-94-NL |
| CCMO | NL81063.056.22 |