Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644040
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Study of TeriQ Patch in Healthy Adult Female Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-Label Active-Controlled 3-Way Incomplete Block Crossover Single Escalating Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of TeriQ Patch in Healthy Adult Female Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a single center open-label active-controlled 3-way incomplete block crossover randomized and single escalating dose study
Detailed Description:
This study will compare TeriQ Patch with two active comparators Teribone Injection and Forteo Injection to evaluate the safety tolerability and pharmacokinetics of TeriQ Patch in healthy adult female participants
This study will be a single escalating dose study in which 24 healthy adult female participants will receive 2 of the 3 TeriQ Patch dose levels 282 μg 565 μg and 1130 μg and 1 of the control drugs Teribone Inj or Forteo Inj in 3 separate time periods There will be a washout period of approximately 1 week between each treatment period The control drug will be administered as a subcutaneous SC injection and the test drug will be administered as a dermal patch
This study will be a single escalating dose study in which 24 healthy adult female participants will receive 2 of the 3 TeriQ Patch dose levels 282 μg 565 μg and 1130 μg and 1 of the control drugs Teribone Inj or Forteo Inj in 3 separate time periods There will be a washout period of approximately 1 week between each treatment period The control drug will be administered as a subcutaneous SC injection and the test drug will be administered as a dermal patch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None