NCT06372652

A Phase 1 Study of TE-8214 Solution in Healthy Volunteers

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Immunwork, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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 1:1. 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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	TE-8214 - SAD	Cohort 1 - Single subcutaneous dose of 0.6 mg Cohort 2- Single subcutaneous dose of 1.2 mg Cohort 3 - Single subcutaneous dose of 2.0 mg Cohort 4 - Single subcutaneous dose of 3.0 mg or 4.0 mg Cohort 5 (Optional) - Single subcutaneous dose of 6.0 mg
DRUG	Placebo	Single subcutaneous dose of matching placebo across the cohorts

Timeline

• Start date: 2024-06-18
• Primary completion: 2024-10-10
• Completion: 2024-12-06
• First posted: 2024-04-18
• Last updated: 2025-05-20

Locations

1 site across 1 country: Australia