Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03443830
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2018-02-08
Brief Title:
Safety and Tolerability of an Antibody Against Zika Virus Tyzivumab in Humans
Sponsor:
Tychan Pte Ltd
Organization:
Tychan Pte Ltd
Study Overview
Official Title:
Phase 1 First in Human Time Lagged Parallel-Group Single Ascending Dose Study of Tyzivumab in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 presenceabsence of AESAE PK and ADA
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 presenceabsence of AESAE PK and ADA
Detailed Description:
Dose escalation in this study will include 24 healthy volunteers in six 6 dose cohorts
02 mgkg N 2
05 mgkg N 2
1 mgkg N 2
5 mgkg N 6
10 mgkg N 6
20 mgkg 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 mgkg 5 mgkg 10 mgkg 20 mgkg 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 t12
volume of distribution Vd
clearance CL in serum PK will be assessed at pre-dose 05 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
02 mgkg N 2
05 mgkg N 2
1 mgkg N 2
5 mgkg N 6
10 mgkg N 6
20 mgkg 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 mgkg 5 mgkg 10 mgkg 20 mgkg 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 t12
volume of distribution Vd
clearance CL in serum PK will be assessed at pre-dose 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None