NL-OMON53655
Completed
Not Applicable
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 - SAD and MAD to assess safety, tolerability and PK of INF904
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- InflaRx GmbH
- Enrollment
- 86
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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