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

NCT06372652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Immunwork, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2024-10-10
Completion
2024-12-06

Countries

  • Australia

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372652 on ClinicalTrials.gov