A Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune System's Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo. - Immune system response to PNEUMOVAX 23 with efgartigimod IV

Argenx BV0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. At least18 years of age at the time of signing the informed consent form
•2. Healthy as determined by medical evaluation including medical history,
•physical examination, laboratory tests, and cardiac monitoring
•3. Body mass index (BMI) between 18 kg/m2 to 30 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.
•5. Capable of giving signed informed consent as described in Appendix 1,
•Section 10.1.3, which includes compliance with the requirements and
•restrictions listed in the ICF and in this protocol
•6. Abstains from smoking for at least 3 months prior to screening
•7. Negative urine drug screen (amphetamines, barbiturates, benzodiazepines,
•cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at
•screening and on day -1
•8. Negative alcohol urine test at screening and on day -1
•9. Agrees to restrict excessive strenuous physical activities 96 hours prior to
•screening, 96 hours prior to the visits in the treatment period (D-1, D7, D14,
•and D21), and 96 hours prior to the visits in follow-up period

•1. Clinically significant active or chronic bacterial, viral, including or
•fungal infection at day -1
•2. History of malignancy unless deemed cured by adequate treatment with no
•evidence of recurrence for >=3 years before the first administration of study
•intervention. Participants with the following
•cancers can be included at any time:
•a. Adequately treated basal cell or squamous cell skin cancer
•b. Carcinoma in situ of the cervix
•c. Carcinoma in situ of the breast
•d. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
•3. Clinical evidence of other significant serious diseases, a recent major
•surgery, or any other condition that, in the opinion of the investigator, could
•confound the results of the study or put the participant at undue risk
•4. Use of an investigational product within 2 months or 5 half-lives (whichever
•is longer) before the first dose of study intervention
•5. Use of any monoclonal antibody within 3 months prior to the initial study
•intervention administration
•For more exclusion criteria see the protocol.

发起方