healthy volunteers None
Conditions
Interventions
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.
Sponsors
InflaRx GmbH
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and Part 3: • Adverse events • Physical examination • ECG assessments • 12-lead ECG continuous cardiac monitoring • Vital signs • Clinical safety laboratory assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed