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Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in Humans

NCT03443830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-10

No results posted yet for this study

Summary

Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly spreading throughout the continents since the first epidemic was reported in the French Polynesian islands.

Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.

This is a Phase 1, first in human, time-lagged, parallel-group, single dose ascending (6 dose cohorts), Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in 24 flaviviral naïve healthy adult volunteers.

Tyzivumab will be administered once through single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 98 days from the date of screening. Post-trial monitoring through weekly telephone calls will continue from Day 85 post-dose onwards for another three (3) more months.

The main objective of this study is to evaluate safety of Tyzivumab in healthy adult volunteers through assessment of subject vital signs, clinical laboratory results, ECG, presence/absence of AE/SAE, PK and ADA.

Conditions

  • Treatment of Acute Zika Virus Infection

Interventions

DRUG

Tyzivumab

Tyzivumab Injection, (100 mg/5 mL/Vial), Zika Virus (ZIKV) Monoclonal Antibody (mAb) Infused over 30 minutes

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Singapore Clinical Research Institute

    collaborator OTHER

  • National University of Singapore

    collaborator OTHER

  • National University Hospital, Singapore

    collaborator OTHER

  • Tychan Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Jenny Low, MBBS · SingHealth Investigational Medicine Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2018-09-12
Completion
2018-12-04

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443830 on ClinicalTrials.gov