A randomised, investigator and subject blinded, placebo-controlled study to determine the safety, tolerability, and pharmacokinetics of INF904 in healthy subjects after single and multiple ascending doses

Completed

• Conditions: healthy volunteers; None

• Registration Number: NL-OMON53655
• Lead Sponsor: InflaRx GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 86

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1 and Part 3:<br /><br>• Adverse events<br /><br>• Physical examination<br /><br>• ECG assessments<br /><br>• 12-lead ECG continuous cardiac monitoring<br /><br>• Vital signs<br /><br>• Clinical safety laboratory assessments</p><br>