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

NCT06372652 | Completed Phase 1 DMC

• 1 other identifier: TE-8214-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (6)

• Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs)

  From administration of IP on Day 1 until the EOS/ET visit (Day 84) post dose

• Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events

  From screening until the EOS/ET visit (Day 84) post dose

• Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs)

  On Day 1, 0 hour, 6 hours, 12 hours, 24 hours, 48 hours,72 hours, 96 hours, 168 hours post dose

• Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings

  From Screening until EOS/ET (Day 84) post dose

• Safety and tolerability of TE-8214 by the changes in physical examination findings

  At Screening, Day -1, Day 2, Day 8, Day 28, Day 56, Day 84 post dose

• Safety and tolerability of TE-8214 by the changes in ECG findings

  At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose

Secondary Outcomes (3)

• PK Parameters: Maximum observed concentration (Cmax)

  On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose

• PK Parameters: Time to maximum observed concentration (Tmax)

  On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose

• PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)

  On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose

Study Arms (2)

SAD Cohort

EXPERIMENTAL

Each participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional)

Drug: TE-8214 - SAD

Placebo

EXPERIMENTAL

Each participant will receive matching volume doses of Placebo administered by subcutaneous injection

Drug: Placebo

Interventions

TE-8214 - SAD DRUG

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

SAD Cohort

Placebo DRUG

Single subcutaneous dose of matching placebo across the cohorts

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult, between 18 and 64 years old (inclusive, at the time of informed consent).
• In good general health, as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening and/or before the administration of IP at the discretion of the PI or designee.
• Sign informed consent forms which include an explanation of the nature of the study, and the expected compliance with the requirements and restrictions of the study.

You may not qualify if:

• Any abnormal laboratory values at Screening that are considered clinically significant by the PI or designee, or evidence of clinically significant abnormal findings at the physical examination at Screening, or significant illness within 2 weeks prior to dosing.
• Have known allergies to octreotide, somatostatin analogs, or related compounds.
• Have abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant, including, but not limited to: PR interval \> 220 ms, QTcF \> 450 ms (males) or \> 470 ms (females), and/or arrythmias.
• History of clinically significant allergy (including anaphylaxis), history or clinical evidence of pancreatic injury or pancreatitis.
• History of B12 deficiency.
• History of hypothyroidism, or TSH \> 4 mIU/L at Screening.
• Any individual with a known history of diabetes mellitus, or HbA1c ≥ 6.5% at Screening. Individuals with previous gestational diabetes are eligible to participate, provided they do not currently have diabetes.
• Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion.
• Males must use an acceptable, highly effective double contraception from Screening until study completion and must not donate sperm until at least 90 days after the last dose of study drug.
• Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
• Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.

Sponsors & Collaborators

• Immunwork, Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: June 18, 2024
• Primary Completion: October 10, 2024
• Study Completion: December 6, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)