Study in Healthy Volunteers Evaluating Safety & Pharmacokinetics of Zika

Status Completed

Clinical Trial Summary

Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.

Clinical Trial Description

This study will be evaluating safety and pharmacokinetics (PK) of one dose level of ZIKV-IG (50 mL) in healthy adult volunteers. The study is a single-center, double-blind, randomized and placebo-controlled design. The primary objective is to assess safety of intravenously (IV) administered ZIKV-IG, while the secondary objective is to determine the PK profile of ZIKV-IG in healthy adult volunteers. There will be a total of 30 subjects enrolled into the study; dosing of the first six subjects will be staggered over three separate days, wherein two subjects per day will be randomized 1:1 to either receive 50 mL of placebo IV or 50 mL of ZIKV-IG IV (the total amount of gamma immune globulin [IgG] protein from a single 50mL dose is 4.65g). After the first six subjects are dosed, the remaining 24 subjects will be randomized 2:1 to receive either ZIKV-IG or placebo. A safety monitoring committee will review safety data (collected up to 3 days post-dosing) of the first 12 dosed subjects prior to dosing of the remaining 18 subjects. Overall, there will be 19 subjects randomized to receive ZIKV-IG and 11 subjects randomized to receive placebo on Day 1. On Day 1 (post-dose at 1 hour, 3 hours, 8 hours) and Day 2, safety and PK assessments will be conducted while the subjects are in the Phase 1 clinic. After the discharge on Day 2, the subjects will come back to the clinic for safety and PK assessments on Days 3, 4, 6, 8, 10, 12, 15, 22, 29, 43, 57 and 85. Total study duration for each subject will be up to 4 months (from screening to Day 85). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03624946
Study type	Interventional
Source	Emergent BioSolutions
Contact
Status	Completed
Phase	Phase 1
Start date	June 27, 2018
Completion date	March 6, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04697147` - Zika and Neurodevelopment Among Infants in Grenada	N/A
Completed	`NCT03631719` - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Completed	`NCT02952833` - ZIKA Vaccine in Naive Subjects	Phase 1
Terminated	`NCT03055585` - Applying Wolbachia to Eliminate Dengue	N/A
Not yet recruiting	`NCT05589012` - Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
Completed	`NCT02963909` - A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects.	Phase 1
Completed	`NCT03110770` - VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents	Phase 2
Recruiting	`NCT06334393` - Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults	Phase 1
Terminated	`NCT03161444` - Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection.	N/A
Completed	`NCT03008122` - Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area	Phase 1
Completed	`NCT04478656` - Safety and Immunogenicity of BBV121	Phase 1
Completed	`NCT03330600` - Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome	N/A
Completed	`NCT05041439` - Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico	N/A
Recruiting	`NCT03255369` - Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF)
Completed	`NCT03206541` - Neurologic Manifestations of the Arbovirus Infection in Colombia
Completed	`NCT03425149` - Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults	Phase 1
Completed	`NCT04033068` - Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)	Phase 1
Completed	`NCT03679728` - Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
Withdrawn	`NCT03204409` - ZIKAlliance Natural History Study
Completed	`NCT03776903` - Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms