NL-OMON53655已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
排除标准
- •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
研究者
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