Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372652
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
A Phase 1 Study of TE-8214 Solution in Healthy Volunteers
Sponsor:
Immunwork Inc
Organization:
Immunwork Inc
Study Overview
Official Title:
A Randomized Double-blinded Placebo-controlled Phase 1 Study of a Single Dose of a Subcutaneous Ultra-Long-Acting Somatostatin Analog TE-8214 Solution to Investigate the Safety Tolerability and Pharmacokinetics in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This is a Phase 1 first-in-human randomized double-blinded placebo-controlled study to evaluate the safety tolerability and PK of TE-8214 in healthy volunteers The study will assess single ascending doses SAD of TE-8214
Detailed Description:
This study will enroll approximately 32 eligible healthy volunteers
The main purpose of this study is to evaluate the safety tolerability and PK of single ascending doses SAD of TE-8214 This study will involve 4 groups called Cohorts of 8 participants at a time with each group receiving a higher dose than the group before A further 8 participants may be randomized into an optional cohort
Each participant will receive 1 dose of TE-8214 solution or placebo in a randomized double-blinded manner and the IP will be administered by subcutaneous injection into the abdomen For each cohort there will be a sentinel group and a main group In the sentinel group 2 participants will be randomized to TE-8214 or placebo at a ratio of 11 if there are no safety concerns this will be followed by the main group dosing at the discretion of the investigator
The total duration of the study for each participant is up to 16 weeks which consists of 28 days for Screening confinement period of 3 days with dosing on Day 1 and a follow up period until Day 84
The main purpose of this study is to evaluate the safety tolerability and PK of single ascending doses SAD of TE-8214 This study will involve 4 groups called Cohorts of 8 participants at a time with each group receiving a higher dose than the group before A further 8 participants may be randomized into an optional cohort
Each participant will receive 1 dose of TE-8214 solution or placebo in a randomized double-blinded manner and the IP will be administered by subcutaneous injection into the abdomen For each cohort there will be a sentinel group and a main group In the sentinel group 2 participants will be randomized to TE-8214 or placebo at a ratio of 11 if there are no safety concerns this will be followed by the main group dosing at the discretion of the investigator
The total duration of the study for each participant is up to 16 weeks which consists of 28 days for Screening confinement period of 3 days with dosing on Day 1 and a follow up period until 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?:
None
Is an FDA AA801 Violation?:
None