Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04410809
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-28
Brief Title:
Study Of Safety Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A SINGLE-CENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PARALLEL-GROUP STUDY INVESTIGATING THE SAFETY TOLERABILITY AND PHARMACOKINETICS OF SINGLE- AND MULTIPLE-ASCENDING SUBCUTANEOUS DOSES OF TA-46 IN HEALTHY VOLUNTEERS
Status:
COMPLETED
Status Verified Date:
2020-05
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:
TA-46 single- and multiple-ascending dose study in healthy volunteers to investigate safety and PK The protocol is conducted in four parts Part A - Single Ascending doses of TA46 Part B - Multiple Ascending doses of TA-46 Part C - Comparing 2 formulations 50mgml vs 120mgml TA-46 Part D - Single Ascending dose of TA46 120mgml formulation
The subjects will be in the clinic for 1 period The subjects will be admitted to the clinical research center in the afternoon of Day -1 They will be discharged on Day 4 72 hours post-dose after completion of the assessments After discharge the subjects will return to the clinical research center for ambulatory visits on Days 5 8 10 12 14 and 22
The subjects will be in the clinic for 1 period The subjects will be admitted to the clinical research center in the afternoon of Day -1 They will be discharged on Day 4 72 hours post-dose after completion of the assessments After discharge the subjects will return to the clinical research center for ambulatory visits on Days 5 8 10 12 14 and 22
Detailed Description:
This is a single-center 34-part clinical study in healthy subjects
Part A This is a single-center double-blind randomized placebo-controlled single ascending dose study in healthy subjects The dose escalation is adaptive in nature An estimated number of 5 dose levels will be administered in Part A of the study with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo Depending on evaluation of the data the number of subjects may be adjusted andor additional groups may be added
In this first-in-human study the subjects participating at all dose levels of Part A Groups A1-A5 will be dosed according to a sentinel dosing design to ensure optimal safety This means that initially 2 subjects will be dosed 1 subject with TA-46 and 1 subject with placebo If the safety and tolerability results of the first 24 hours following dosing for the initial subjects are acceptable to the Principal Investigator PI the other 6 subjects 5 active and 1 placebo of that dose level may be dosed
For Groups A1 and A2 TA-46 and placebo will be administered as a sc injection bolus and for Groups A3-A5 TA-46 and placebo will be administered as a sc infusion When TA-46 and placebo will be administered as sc infusion the duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour The dose levels of TA-46 can be increased or decreased based on the results of the previous groups
Part B This is a single-center double-blind randomized placebo-controlled multiple ascending dose study in healthy subjects The dose escalation is adaptive in nature TA-46 will be administered twice weekly for4 weeks An estimated number of 3 dose levels will be administered in Part B of the study with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo Depending on evaluation of the data the number of subjects may be adjusted andor additional groups may be added Based on the results of Groups B1 and B2 of Part B which followed a twice weekly dosing scheme for 4 weeks the dosing scheme of Group B3 will be adapted to once weekly administration for 4 weeks and 31 additional groups Groups B4 to B6 with the same dosing frequency will be added to Part B of the study Depending on evaluation of the data additional groups may be added or planned groups may be skipped
For Group B1 TA-46 and placebo will be administered as a sc injection bolus and for Groups B2 to B64 TA-46 and placebo will be administered as a sc infusion When TA-46 and placebo will be administered as a sc infusion the duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour The dose levels of TA-46 can be increased or decreased based on the results of the previous groups
Administration of a dose level in Part B can be started after completion and review of the corresponding or higher dose level in Part A of the study
Part C This is a single-center single-dose open-label cross-over study in healthy subjects comparing 2 formulations of TA-46 50 mgmL and 120 mgmL A total of 6 subjects will receive Treatment A TA-46 formulation 1 and Treatment B TA-46 formulation 2 randomly assigned over 2 periods with 2 treatment sequences Treatment AB and Treatment BA with 3 subjects per treatment in each sequence
The following treatments are planned to be administered according to the randomization code
Group C1 Treatment A sc administration of 3 mgkg TA-46 formulation 1 Treatment B sc administration of 3 mgkg TA-46 formulation 2TA-46 formulation 1 will be administered as a a sc infusion The duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour TA-46 formulation 2 will be administered as 1-2 sc injections bolus
The subjects will be in the clinic for 2 periods Each period the subjects will be admitted to the clinical research center in the afternoon of Day -1 and they will be discharged on Day 4 72 hours post-dose after completion of the assessments After discharge the subjects will return to the clinical research center for ambulatory visits on Days 6 9 12 16 and 22 of each period
Part D This is a single-center open-label single-dose study in healthy subjects with the TA-46 formulation of 120 mgmL
TA-46 and placebo will be administered as a sc infusion The duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour Depending on evaluation of the data additional groups may be added or planned groups may be skipped
Part A This is a single-center double-blind randomized placebo-controlled single ascending dose study in healthy subjects The dose escalation is adaptive in nature An estimated number of 5 dose levels will be administered in Part A of the study with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo Depending on evaluation of the data the number of subjects may be adjusted andor additional groups may be added
In this first-in-human study the subjects participating at all dose levels of Part A Groups A1-A5 will be dosed according to a sentinel dosing design to ensure optimal safety This means that initially 2 subjects will be dosed 1 subject with TA-46 and 1 subject with placebo If the safety and tolerability results of the first 24 hours following dosing for the initial subjects are acceptable to the Principal Investigator PI the other 6 subjects 5 active and 1 placebo of that dose level may be dosed
For Groups A1 and A2 TA-46 and placebo will be administered as a sc injection bolus and for Groups A3-A5 TA-46 and placebo will be administered as a sc infusion When TA-46 and placebo will be administered as sc infusion the duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour The dose levels of TA-46 can be increased or decreased based on the results of the previous groups
Part B This is a single-center double-blind randomized placebo-controlled multiple ascending dose study in healthy subjects The dose escalation is adaptive in nature TA-46 will be administered twice weekly for4 weeks An estimated number of 3 dose levels will be administered in Part B of the study with at each dose level 6 subjects randomized to receive TA-46 and 2 to receive placebo Depending on evaluation of the data the number of subjects may be adjusted andor additional groups may be added Based on the results of Groups B1 and B2 of Part B which followed a twice weekly dosing scheme for 4 weeks the dosing scheme of Group B3 will be adapted to once weekly administration for 4 weeks and 31 additional groups Groups B4 to B6 with the same dosing frequency will be added to Part B of the study Depending on evaluation of the data additional groups may be added or planned groups may be skipped
For Group B1 TA-46 and placebo will be administered as a sc injection bolus and for Groups B2 to B64 TA-46 and placebo will be administered as a sc infusion When TA-46 and placebo will be administered as a sc infusion the duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour The dose levels of TA-46 can be increased or decreased based on the results of the previous groups
Administration of a dose level in Part B can be started after completion and review of the corresponding or higher dose level in Part A of the study
Part C This is a single-center single-dose open-label cross-over study in healthy subjects comparing 2 formulations of TA-46 50 mgmL and 120 mgmL A total of 6 subjects will receive Treatment A TA-46 formulation 1 and Treatment B TA-46 formulation 2 randomly assigned over 2 periods with 2 treatment sequences Treatment AB and Treatment BA with 3 subjects per treatment in each sequence
The following treatments are planned to be administered according to the randomization code
Group C1 Treatment A sc administration of 3 mgkg TA-46 formulation 1 Treatment B sc administration of 3 mgkg TA-46 formulation 2TA-46 formulation 1 will be administered as a a sc infusion The duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour TA-46 formulation 2 will be administered as 1-2 sc injections bolus
The subjects will be in the clinic for 2 periods Each period the subjects will be admitted to the clinical research center in the afternoon of Day -1 and they will be discharged on Day 4 72 hours post-dose after completion of the assessments After discharge the subjects will return to the clinical research center for ambulatory visits on Days 6 9 12 16 and 22 of each period
Part D This is a single-center open-label single-dose study in healthy subjects with the TA-46 formulation of 120 mgmL
TA-46 and placebo will be administered as a sc infusion The duration of the sc infusion will be dependent on the volume to be administered but will not exceed a period of 1 hour Depending on evaluation of the data additional groups may be added or planned groups may be skipped
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C4181002 | OTHER | Alias Study Number | None |
| 2017-003596-55 | EUDRACT_NUMBER | None | None |