A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled Plasmodium falciparum Sporozoite Challenge Model in Healthy Participants - Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Merck0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Merck
入组人数: 50

研究概览入排标准研究者记录与标识符相似试验

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 99（—）

入选标准

•1. Are between 18 and 45 years of age at the time of signing the informed
•Type of Participant and Disease Characteristics
•2. Are overtly healthy as determined by medical evaluation, including no
•clinically significant abnormality identified on physical examination or
•laboratory evaluation and no active clinically significant disorder, condition,
•infection or disease that would pose a risk to participant safety or interfere
•with the study evaluation, procedures or completion.
•3. Have a body weight within 50 to 100 kg and body mass index within the range
•19.0 to 29.9 kg/m2 (inclusive).
•4. Are male or female
•Contraceptive use by males or females will be consistent with local regulations
•on contraception methods for those participating in clinical studies.
•* Male Participants:
•Agree to the following during the study intervention period and for at least
•120 days after the day of the study intervention dose (covering a full sperm
•cycle of 90 days starting after 5 half-lives of last dose of study intervention:
•* Refrain from donating sperm
•PLUS, either:
•* Abstain from intercourse with a woman of childbearing potential
•* Use a male condom:
•* When having sexual intercourse with a woman of childbearing potential, who is
•not currently pregnant, and advise her to use a highly effective contraceptive
•method with a failure rate of < 1% per year, as described in Appendix 3
•Contraception, since a condom may break or leak.
•* Female Participants:
•* Have a negative serum test at Screening and a highly sensitive urine
•pregnancy test within 24 hours before the first study intervention (DVI) and
•within 24 hours before the second study intervention (M5717) administration, as
•required by local regulations. [If a urine test cannot be confirmed as negative
•(e.g., 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].
•* Are not pregnant or breastfeeding, and at least one of the following
•conditions applies:
•* Not a woman of childbearing potential
•* At least 1 year post-menopausal (amenorrhea * 12 months and
•follicle-stimulating hormone (FSH) * 40 mIU/mL) at Screening;
•* Surgically sterile (bilateral oophorectomy, hysterectomy or bilateral
•salpingectomy; tubal ligation alone is not sufficient).
•* If a woman of childbearing potential, use a highly effective contraceptive
•method (i.e., with a failure rate of < 1% per year), preferably with low user
•dependency, as described in Appendix 3 for the following time periods:
•* Before the first dose of the study intervention(s), if using hormonal
•contraception:
•* Has completed at least one 4-week cycle of an oral contraception pill and
•either had or has begun her menses
•* Has used a depot contraceptive or extended-cycle oral contraceptive for at
•least 28 days and has a documented negative pregnancy test using a highly
•sensitive assay.
•* During the intervention period
另有 4 项未显示

排除标准

•Medical Conditions
•1. 12-Lead electrocardiogram (ECG) outside normal range (QTcF > 450 ms, PR
•interval > 215 ms, or QRS > 120 ms) and deemed clinically relevant by the
•Investigator.
•2. Supine systolic blood pressure > 140 or < 90 mmHg, diastolic blood pressure
•> 90 or < 50 mmHg, and pulse rate > 90 or < 50 beats per minute (min) at
•Screening and at Admission on Day -1 (Any abnormal blood pressure or pulse rate
•results may be repeated once and if the repeat result is within the normal
•range, it is not considered to have met the exclusion criterion).
•3. Seropositive for human immunodeficiency virus (HIV) I and II antibody or
•antigen), hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg]), or
•hepatitis C virus (HCV; antibody) tests.
•4. Liver function tests (see Appendix 5 Liver Safety: Suggested Actions and
•Follow-up Assessments) above the upper limit of normal (ULN) (> 3xULN) (as
•specified in the Laboratory Manual) the day before DVI / study intervention
•administration (Day -1).
•5. History or presence of diagnosed food or known drug allergies (including but
•not limited to allergy to any of the antimalarial rescue medications to be used
•in the study), or history of anaphylaxis or other severe allergic reactions.
•Note: Participants with seasonal allergies/hay fever, house dust mite allergy,
•or allergy to animals that are untreated and asymptomatic at the time of dosing
•can be enrolled in the study.
•6. History of a serious psychiatric condition that may affect participation in
•the study or preclude compliance with the protocol.
•7. Any surgical or medical condition possibly affecting drug absorption (e.g.
•cholecystectomy, gastrectomy, bowel disease), distribution, metabolism or
•8. Any history of gallbladder disease, including cholecystitis and/or
•cholelithiasis.
•9. Any condition that in the opinion of the investigator would jeopardize the
•safety or rights of a person participating in the study or would render the
•person unable to comply with the protocol.
•10. Frequent headaches of clinical relevance and/or migraine, recurrent nausea,
•and/or vomiting (> 2 times per month).
•11. Ingestion of any poppy seeds within 24 hours prior to each Drug Abuse
•12. Personal history of malaria or medical history of possible exposure to
•13. Presence of acute infectious disease or fever (i.e., sublingual temperature
•* 38.0°C) within the 5 days prior to DVI with malaria sporozoites.
•Prior/Concomitant Therapy
•14. Use of medications known to interact with atovaquone-proguanil (Malarone)
•or artemether-lumefantrine (Riamet) such as cimetidine, metoclopramide or
•antacids, or an anticipated requirement for the use of these at any point
•during the study period (see also Section 5.1).
•15. Use of systemic antibiotics with known antimalarial activity within 30 days
•(or 5 half-lives whichever is longer) of first study intervention
•administration (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline,
•clindamycin, erythromycin, fluoroquinolones or azithromycin) or an anticipated
•requirement for the use of these during the study period.
•16. Use of any prescription drugs, herbal supplements (e.g., St John's Wort) or
•over-the-counter medication within 7 days or five half-lives (whichever is
•longer) prior to the first study intervention ad

研究者

发起方

Merck

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