A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF).
Condition or disease
Drug: GalidesivirDrug: Placebo
This is a randomized, double-blind, placebo-controlled dose-ranging study to evaluate the pharmacokinetics (PK), safety, and antiviral effects of galidesivir administered via intravenous (IV) infusion vs. placebo in adult subjects with Yellow fever (YF). The study will be conducted in two parts. Part 1 will be a dose ranging study where subjects with YF will be administered escalating dose regimens of galidesivir twice daily for 7 days. Eight subjects will be enrolled in each cohort: 6 to receive galidesivir and 2 will receive placebo. Part 2 of the study is an expansion cohort, where the optimized regimen of galidesivir will be administered to more subjects randomized in a 2:1 manner to galidesivir or placebo. The optimized regimen will be selected based on safety, viral load reduction, improvement in YF signs and symptoms and mortality. Thirty subjects are planned for Part 2.
A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever
Estimated Study Start Date :
April 15, 2019
Estimated Primary Completion Date :
July 30, 2020
Estimated Study Completion Date :
July 30, 2020
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ability to provide written informed consent
Males and nonpregnant, non-breast-feeding females, aged 18 years or older
Subject weight ≥ 50 kg (110 lb.)
Positive test for YFV by molecular amplification of the virus in the blood
First onset of symptoms of YF occurring within the previous 7 days
Male and female subjects must agree to the contraception requirements and must meet the inclusion criteria regarding contraception as outlined in the protocol
CLCR of at least 60 mL/min by Cockcroft-Gault equation
AST < 5000 u/L
Indirect bilirubin < 1.5 mg/dL
Neutrophil count < 7500 /mm3
International Normalized Ratio (INR) < 1.5
Any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
Employment by the study site, or an immediate family relationship to either study site employees or Sponsor employee
Lack of suitable veins for venipuncture/cannulation as assessed by the Investigator at Screening
Participation in any other investigational drug or vaccine study currently or within the past 30 days
Diagnosis of YF vaccine-related viscerotropic disease
Subjects with hepatic encephalopathy as defined by Conn Score ≥ 1.
Subject has severe immunosuppression or immunodeficiency, leukemia, lymphoma, thymic disease, generalized malignancy, or radiation therapy (within the past 3 months), or is undergoing current treatment with immunosuppressive drugs, defined as drugs that impair immune responses to infections
A treatment plan for YF that would include concomitant administration of antiviral medications