Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471530
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-06
Brief Title:
A Study to Investigate the Safety and Tolerability of TE-8105 in OverweightObese Participants Without Diabetes
Sponsor:
Immunwork Inc
Organization:
Immunwork Inc
Study Overview
Official Title:
A Phase 1 Open-label Single-Ascending Dose and Multiple-Ascending Dose Study to Investigate the Safety and Tolerability of TE-8105 Administered Subcutaneously in OverweightObese Participants Without Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This is a Phase 1 first-in-human prospective open-label study to evaluate the safety tolerability PK and PD of TE-8105 in overweightobese participants without diabetes Study TE-8105-101 consists of 2 parts Part A single-ascending dose SAD and Part B multiple-ascending dose MAD
Detailed Description:
Part A consists of 4 cohorts with an optional adaptive cohort which may be opened if needed approximately 24 eligible participants will be assigned to Part A SAD 6 participants in each cohort Part A is designed to evaluate the safety and tolerability of a single dose of 05 mg 075 mg 15 mg or 25 mg and 3 mg or 5 mg TE-8105 Each participant will receive one dose of TE-8105 injection via subcutaneous SC injection into the abdomen administered on Day 1
Part B consists of 2 cohorts Approximately 12 participants will be assigned to Part B MAD 6 participants in each cohort Part B is designed to evaluate the safety and tolerability of multiple SC doses of 05 mg or 15 mg and 10 mg or 3 mg TE-8105 once every 2 weeks Q2W The dose levels and dosing interval of Part B may be adjusted based on the results of Part A Each participant will receive 5 doses of TE-8105 injection via SC injection into the abdomen
Progression from Part A to Part B will be based on the recommendation of the SRC
Part B consists of 2 cohorts Approximately 12 participants will be assigned to Part B MAD 6 participants in each cohort Part B is designed to evaluate the safety and tolerability of multiple SC doses of 05 mg or 15 mg and 10 mg or 3 mg TE-8105 once every 2 weeks Q2W The dose levels and dosing interval of Part B may be adjusted based on the results of Part A Each participant will receive 5 doses of TE-8105 injection via SC injection into the abdomen
Progression from Part A to Part B will be based on the recommendation of the SRC
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