We will investigate how safe the new compound INF904 is and how well it is tolerated when it is used by healthy subjects.We also investigate how quickly and to what extent INF904 is absorbed, transported, and eliminated from the body. In addition,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
healthy volunteers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1 and Part 3:
• Adverse events
• Physical examination
• ECG assessments
• 12-lead ECG continuous cardiac monitoring
• Vital signs
• Clinical safety laboratory assessments
Secondary outcome
Part 1:
• Maximum observed plasma concentrations (Cmax)
• Systemic exposure, defined as the AUCinf
• Time of occurrence of tmax
• Other derived pharmacokinetics parameters - AUClast, t*, Vz/F, Cl/F
• Intra-subject comparison of AUClast, AUCinf, and Cmax after dosing with
INF904 at various capsule strengths.
Part 3:
• Maximum observed plasma concentrations (Cmax)
• Systemic exposure, defined as the AUC0-12 and AUC0-24
• Time of occurrence of tmax
• Other derived pharmacokinetics parameters - t*, Vz/F, Cl/F, peak-trough ratio
(PTR)
• Maximum observed plasma concentrations (Cmax_ss)
• Systemic exposure, defined as the AUC
• Time of occurrence of tmax
• Other derived pharmacokinetics parameters - AUC0-t, t*, Vz/F, Cl/F,
accumulation ratios (RA_AUC, RA_Cmax), peak-trough ratio (PTR)
• Inter-subject comparison of AUClast, AUCinf, and Cmax after dosing with
INF904 in fasted states.
Background summary
INF904 is a new compound that may potentially be used for the treatment of
inflammatory diseases. INF904 works by inhibiting the so called C5aR1 receptor,
preventing C5a from binding. C5a is a highly inflammatory protein which
activates multiple pathways of the innate and developed immune system. From
research it is known that this protein is involved in a number of inflammatory
diseases, including inflammatory bowel disease, rheumatoid arthritis and
systemic lupus erythematosus. In the future INF904 can possible be used for the
treatment of these inflammatory diseases.
Study objective
We will investigate how safe the new compound INF904 is and how well it is
tolerated when it is used by healthy subjects.
We also investigate how quickly and to what extent INF904 is absorbed,
transported, and eliminated from the body. In addition, we look at the effect
of INF904 on CD11b.
We compare the effects of INF904 with the effects of a placebo.
INF904 has not been administered to humans before. It has been extensively
tested in the laboratory and on animals.
Study design
Part 1:
In total the volunteer will visit the research center 3 times if he/she
participates in Group 1, 2, 3, 5, 6 or an alternative Group:
- 1 day of screening
- Stay in the research center for 1 period of 8 days (7 nights)
- 1 follow-up visit
The volunteer will be given 3, 10, 30, 60, 90, 120, 180 or 240 mg INF904 or
placebo as oral capsule(s) with 240 milliliters (mL) of (tap) water.
In total the volunteer will visit the research center 5 times if he/she
participates in Group 4:
- 1 day of screening
- Stay in the research center for 3 periods of 8 days (7 nights)
- 1 follow-up visit
The volunteer will be given 60 mg INF904 or placebo in each of three periods as
oral capsule(s) with 240 milliliters (mL) of (tap) water.
Part 3:
In total the volunteer will visit the research center 3 times:
- 1 day of screening
- Stay in the research center for 1 period of 22 days (21 nights)
- 1 follow-up visit
The volunteer will be given 30, 60, 90 or 120 mg INF904 or placebo once or
twice daily as oral capsule(s) with 240 milliliters (mL) of (tap) water.
Intervention
Part 1:
Groups 1, 2, 3, 5, 6 or alternative group): The volunteer will be given 3, 10,
30, 60, 90, 120, 180 or 240 mg INF904 or placebo as oral capsule(s) with 240
milliliters (mL) of (tap) water.
Group 4: The volunteer will be given 60 mg INF904 or placebo in each of three
periods as oral capsule(s) with 240 milliliters (mL) of (tap) water.
Part 3: The volunteer will be given 30, 60, 90 or 120 mg INF904 or placebo once
or twice daily as oral capsule(s) with 240 milliliters (mL) of (tap) water.
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula can sometimes lead to inflammation, swelling, hardening of the vein,
blood clotting, and bleeding in the environment (bruising) of the puncture
site. In some individuals, a blood draw can sometimes cause pallor, nausea,
sweating, low heart rate, or drop in blood pressure with dizziness or fainting.
Also, in very rare cases, it can lead to an injury to a nerve with e.g. sensory
deficits in certain areas of the skin through the puncture of the needle. Very
rare motor complications (e.g. limited mobility of the arm) cannot be
completely ruled out.
In total, we will take about 301 milliliters (mL) of blood from you from
screening to follow-up. This amount does not cause any problems in adults. To
compare: a blood donation involves 500 mL of blood being taken each time at
once. If the investigator thinks it is necessary for the safety of a subject,
extra samples might be taken for possible additional testing. If this happens,
the total amount of blood drawn may be more than the amount indicated above.
Heart tracing/telemetry
To make a heart tracing, electrodes will be placed on your arms, chest and
legs. To monitor the electrical activity of your heart over a longer period,
electrodes will be placed on the chest and abdomen. Prolonged use of these
electrodes can cause skin irritation.
Coronavirus test
Samples for the coronavirus test will be taken from the back of your nose and
throat using swabs. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
your throat may cause you to gag. When the sample is taken from the back of
your nose, you may experience a stinging sensation and your eyes may become
watery. Corona tests will be performed according to ICON policy
Winzerlaer Strasse 02
Jena, Germany 07745
NL
Winzerlaer Strasse 02
Jena, Germany 07745
NL
Listed location countries
Age
Inclusion criteria
1. Male or female participant must be 18 to 55 years of age inclusive, at the
time of signing the informed consent.
2. Participants who are overtly healthy as determined by medical evaluation
including medical history, physical examination, laboratory tests, and cardiac
monitoring.
3. Body weight at least 50 kg and body mass index (BMI) within the range 18.0
and 30.5 kg/m2 (inclusive)
4. Contraceptive use by men and women should be consistent with local
regulations regarding the methods of contraception for those participating in
clinical studies.
Male participants:
Male subjects, if not surgically sterilised, must agree to use adequate
contraception and not donate sperm from admission to the clinical research
centre until 90 days after the ESV. Adequate contraception for the male subject
(and his female partner, if she is of childbearing potential) is defined as
using hormonal contraceptives or an intrauterine device combined with at least
1 of the following forms of contraception: a diaphragm, a cervical cap, or a
condom. Total abstinence from heterosexual intercourse, in accordance with the
lifestyle of the subject, is also acceptable.
Female participants:
Female subject must be either:
• Post-menopausal (defined as at least 1 year without any menses) prior to
screening; or
• Pre-menarchal prior to screening; or
• Documented surgically sterile or status post-hysterectomy (at least 1 month
prior to screening); or
• If of childbearing potential, must have a negative urine pregnancy test at
screening and admission and must be using highly effective contraception.
• Female subjects of childbearing potential who have a fertile male sexual
partner must agree to use adequate contraception until 180 days after the ESV.
Adequate contraception is defined as using hormonal contraceptives or an
intrauterine device combined with at least 1 of the following forms of
contraception: a diaphragm, a cervical cap, or a condom. True abstinence: When
this is in line with the preferred and usual lifestyle of the subject.
(Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation
methods] and withdrawal are not acceptable methods of contraception).
5. Capable of giving signed informed consent as described in Appendix 1 which
includes compliance with the requirements and restrictions listed in the
informed consent form (ICF) and in this protocol.
Further criteria apply
Exclusion criteria
1. Female subject who has been pregnant within 6 months before screening
assessment or breastfeeding or lactating within 3 months before screening.
2. Known or suspected hypersensitivity to INF904, or any components of the
formulation used.
3. Any clinically significant history of allergic conditions (including drug
allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated,
asymptomatic, seasonal allergies at time of dosing).
4. Any history or evidence of any clinically significant cardiovascular,
gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic,
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other
major disease or malignancy, as judged by the Investigator.
5. The subject has/had febrile illness or symptomatic, viral, bacterial
(including upper respiratory infection), or fungal (non-cutaneous) infection
within 1 week prior to admission to the clinical unit.
Further criteria apply
Design
Recruitment
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 | EUCTR2022-002765-14-NL |
| CCMO | NL82465.056.22 |