NCT03443830

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

Phase 1 First in Human, Time Lagged, Parallel-Group, Single Ascending Dose Study of Tyzivumab in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tychan Pte Ltd. · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Dose escalation in this study will include 24 healthy volunteers in six (6) dose cohorts: * 0.2 mg/kg, N = 2 * 0.5 mg/kg, N = 2 * 1 mg/kg, N = 2 * 5 mg/kg, N = 6 * 10 mg/kg, N = 6 * 20 mg/kg, N = 6 A minimum of 20-hour interval from the first dosing must take place before the second subject can be dosed within each cohort. No such time interval will be required for dosing of subsequent subjects (third subject onwards) within the same cohort. Dose escalations will be guided by review of clinical signs, adverse events (AEs), and laboratory tests of the prior group (up to Day 7 after dosing) by a safety monitoring committee. In order to assess the safety and tolerability of an intravenous (IV) infusion of Tyzivumab when given to healthy adult volunteers, the following vital signs and tests will be performed: * Blood Pressure * Pulse Rate * Respiratory Rate * Body Temperature * ECG * Urinalysis * Serum Chemistry * Haematology In order to assess Tyzivumab pharmacokinetics (only for doses 1 mg/kg, 5 mg/kg, 10 mg/kg \& 20 mg/kg), the following parameters will be measured: * maximum concentration (Cmax) * time to maximum concentration (Tmax) * area under the curve extrapolated to infinity (AUC0-∞) * AUC calculated from time of administration to the last measurable concentration (AUC0-last) * half-life (t1/2) * volume of distribution (Vd) * clearance \[CL\] in serum PK will be assessed at pre-dose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h, 72 h, 120 h, Day 7, Day 14, Day 28, Day 56 and Day 84. The presence and extent of anti-drug antibody (ADA) production in response to dosing with Tyzivumab will also be assessed at pre-dose, Day 14, Day 56 and Day 84.

Conditions

• Treatment of Acute Zika Virus Infection

Interventions

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

Timeline

• Start date: 2018-02-08
• Primary completion: 2018-09-12
• Completion: 2018-12-04
• First posted: 2018-02-23
• Last updated: 2019-04-10

Locations

1 site across 1 country: Singapore