適用於治療下列病人的新型冠狀病毒疾病(COVID-19，嚴重特殊傳染性肺炎)： •發生肺炎並須給予氧氣治療(開始本品治療時須使用低或高流量氧氣或其他非侵入性呼吸器)的成人與28天大以上且體重至少3公斤之兒童 •不須氧氣治療但惡化成重度COVID-19風險較高的成人與28天大以上且體重至少3公斤之兒童

主要目標 •評估多劑量 Remdesivir（RDV、Veklury®）在健康東亞參與者中的藥物動力學 (PK) 次要目標 •評估多劑量 RDV 在健康東亞參與者中的安全性和耐受性

凍晶乾燥注射劑

Remdesivir

245

100 mg

RDV 和代謝物（GS-704277 及 GS-441524）的血漿 PK 參數（Cmax、Ctrough、AUClast、AUCtau）（如適用）

General
G1. Must be of East Asian descent (Taiwanese, Chinese, Japanese, or Korean) with traceable
maternal and paternal East Asian ancestry of parents and grandparents.
G2. Have the ability to understand and sign a written informed consent form (ICF), which
must be obtained prior to initiation of study procedures.
G3. Be aged 18 through 45 years, inclusive, at screening and at admission.
G4. Be a nonsmoker. The use of nicotine or nicotine-containing products must be
discontinued ≥ 90 days prior to the first dose of study drug.
G5. Participants assigned female at birth and of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
G6. Participants have not donated blood within 56 days of study entry or plasma within
7 days of study entry and must refrain from blood donation from clinic admission, throughout the
study period, and continuing for at least 30 days following the last dose of study drug.
G7. Must be willing and able to comply with all study requirements.
G8. Must, in the opinion of the investigator, be in good health based upon medical history and
physical examination, including vital signs.
Medical History/Physical Characteristics
MH1. Have a calculated body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at screening and at
admission.
MH2. Have a calculated CLcr of at least 90 mL/minute (using the Cockcroft-Gault method
{Cockcroft 1976}) based on serum creatinine and actual body weight as measured at screening
and admission:
Participants assigned male at birth:
(140 − Age [years])  (Weight [kg]) = CLcr (mL/min)
72  (Serum Creatinine [mg/dL])
Participants assigned female at birth:
(140 − Age [years])  (Weight [kg])  0.85 = CLcr (mL/min)
72  (Serum Creatinine [mg/dL])
MH3. Laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations at screening
and admission must be without clinically significant abnormalities as assessed by the
investigator.
MH4. Have liver biometric tests alanine aminotransferase, aspartate aminotransferase, and total
bilirubin at or below the upper limit of normal (ULN) and alkaline phosphatase at or below the
ULN at screening and at admission.

General
G1. Positive serum pregnancy test at screening or positive serum or urine pregnancy test at
admission.
G2. Breastfeeding participant.
G3. Participants who plan to donate eggs, sperm, or to have in vitro fertilization from clinic
admission (Day −1), throughout the study period, and through the required contraception period
G4. Have received any study drug within 30 days prior to study dosing.
Medical History/Physical Characteristics
M1. Have current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance or participant safety, or a positive drug or alcohol test at screening or
admission.
M2. Have a positive test result for HIV-1/2 antibodies, hepatitis B virus surface antigen, or
hepatitis C virus antibody at screening.
M3. Have poor venous access that limits phlebotomy.
M4. Have taken any prescription medications or over-the-counter medications, including
herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins
and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
M5. Have been treated with systemic steroids, immunosuppressant therapies, or
chemotherapeutic agents within 3 months prior to screening or is expected to receive these
agents during the study (eg, corticosteroids, immunoglobulins, other immune- or cytokine-based
therapies).
M6. Have a history of any of the following:
a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema,
psoriasis, or urticaria.
b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).
c) Known hypersensitivity to the study drugs, their metabolites, or to formulation
excipients.
d) Significant cardiac disease (including history of myocardial infarction based on ECG
and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or
dilated cardiomyopathy with left ventricular ejection fraction ≤ 40%); or a family history
of long QT syndrome, or unexplained death in an otherwise healthy individual between
the ages of 1 and 30 years.
e) Syncope, palpitations, or unexplained dizziness.
f) Implanted defibrillator or pacemaker.
g) Liver disease, including Gilbert syndrome.
h) Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid
hypersecretory conditions requiring prolonged (≥ 6 months) medical treatment.
i) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or
intestinal surgery). A history of cholecystectomy is not exclusionary
M7. Have any serious or active medical or psychiatric illness (including depression) that, in
the opinion of the investigator, would interfere with participant treatment, assessment, or
compliance with the protocol. This would include renal, cardiac, hematological, hepatic,
pulmonary (including chronic asthma), endocrine (including diabetes), central nervous,
gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease),
immunodeficiency disorders, active infection, or malignancy that are clinically significant or
requiring treatment.
M8. Requirement for ongoing therapy with or prior use of any prohibited medications listed