NL-OMON53467已完成不适用
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers - A Single Ascending Dose Study of ANX105
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
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
- •Participants are eligible to be included in the study only if all the following
- •criteria apply:
- •1. Participants must be 18 (or the legal age of consent in the jurisdiction in
- •which the study is taking place) to 55 years of age inclusive, at the time of
- •signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2. Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, and laboratory tests.
- •3. Body weight within the range 45 kg to 110 kg and body mass index (BMI)
- •within the range >=18.0 kg/m2 to <=33.5 kg/m2 (inclusive) at the Day -1 visit.
- •Sex and Contraceptive/Barrier Requirements
- •4. Participants who are male or female
- •Contraceptive use by men and women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •a. Male participants:
- •Male participants are eligible to participate if they agree to the following
- •during the intervention period and for at least 90 days after the dose:
- •Refrain from donating fresh unwashed semen
- •Plus, either:
- •o Be abstinent from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long-term and persistent basis) and agree to remain
- •o Must agree to use a male condom and should also be advised of the benefit for
- •a female partner to use a highly effective method of contraception as a condom
- •may break or leak when having sexual intercourse with a woman of childbearing
- •potential who is not currently pregnant
- •b. Female participants:
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and one of the following conditions applies:
- •o Is a woman of nonchildbearing potential (WONCBP) as defined in protocol
- •Appendix 4: Contraceptive and Barrier Guidance.
- •o Is a WOCBP and using a contraceptive method that is highly effective, with a
- •failure rate of <1%, as described in protocol Appendix 4: Contraceptive and
- •Barrier Guidance during the study intervention period and for at least 90 days
- •after the dose. The Investigator should evaluate the potential for
- •contraceptive method failure (eg, noncompliance, recently initiated) in
- •relationship to the first dose of the study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum
- •as required by local regulations) within 24 hours before the first dose of
- •study intervention, see Protocol Section 8.2.7: Pregnancy Testing.
- •o If a urine test cannot be confirmed as negative (eg, an ambiguous result), a
- •serum pregnancy test is required. In such cases, the participant must be
- •excluded from participation if the serum pregnancy result is positive.
- •Additional requirements for pregnancy testing during and after study
- •intervention are outlined in protocol Section 8.2.7: Pregnancy Testing
- •The Investigator is responsible for the review of medical history, menstrual
- •history, and recent sexual activity to decrease the risk for inclusion of a
- •woman with early undetected pregnancy.
- •Informed Consent
- •5. Capable of giving signed informed consent as described in protocol Section
- •10.1.3 which includes compliance with the requirements and restrictions listed
- 另有 1 项未显示
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. History or presence of clinically relevant cardiovascular, respiratory,
- •hepatic, renal, gastrointestinal, endocrinological, hematological, or
- •neurological disorders.
- •2. History or presence of conditions capable of significantly altering the
- •disposition of drugs that constitute a risk when taking the study intervention
- •or interfere with the interpretation of data.
- •3. History of any autoimmune disease (eg, rheumatoid arthritis, systemic lupus
- •erythematosus, multiple sclerosis, autoimmune vasculitis, Guillain-Barré
- •syndrome, autoimmune hepatitis, or psoriasis).
- •4. History of meningitis or septicemia.
- •5. Clinically significant infection (eg, viral, bacterial, fungal, or
- •mycobacterial), with the exception of onychomycosis, within 30 days prior to
- •Day 1 that required medical intervention (not including antibiotic prophylaxis).
- •6. Known genetic deficiencies of the complement cascade system or
- •immunodeficiency.
- •7. Abnormal blood pressure as determined by the Investigator.
- •8. Significant allergies to humanized monoclonal antibodies.
- •9. Clinically significant drug allergies, intolerance to topical
- •corticosteroids, or severe post-treatment hypersensitivity reactions
- •(including, but not limited to, erythema multiforme major, linear
- •immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative
- •dermatitis).
- •10. History or presence of any malignancy (excluding basal cell carcinoma).
- •11. Liver disease or liver function tests such as alanine transaminase (ALT) or
- •aspartate transaminase (AST) >1.5xULN (upper limit of normal), serum total
- •bilirubin (isolated bilirubin >1.5xULN is acceptable if total bilirubin is
- •fractionated and direct bilirubin <35%), or alkaline phosphatase above the
- •12. Known hepatic or biliary abnormalities (except for Gilbert's syndrome or
- •asymptomatic gallstones).
- •13. The following ECG abnormalities at Screening:
- •QRS >120 msec; heart rate <40 beats per minute.
- •Presence of second- or third-degree heart block.
- •QTcF >450 msec for male participants and >470 msec for female participants.
- •The ECG may be repeated twice with a manually measured QTcF and the average of
- •3 manually measure QTcF values will be obtained to determine the participant*s
- •eligibility.
- •PR interval >200 msec and any other clinically relevant abnormality.
- •14. Abnormalities in the lumbar spine were previously known .
- •15. History of clinically significant back pain, back pathology, and/or back
- •injury (for example, degenerative disease, spinal deformity, or spinal surgery)
- •that may predispose the participant to complications or technical difficulty
- •with a lumbar puncture.
- •16. Evidence or history of significant active bleeding or coagulation disorder
- •that affects coagulation or platelet function within 14 days prior to lumbar
- •catheter insertion.
- •17. Allergy to lidocaine (Xylocaine®) or its derivatives.
- •18. Medical or surgical conditions for which lumbar puncture is contraindicated.
- •19. History or presence of anemia or neutropenia.
- 另有 4 项未显示
研究者
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