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AcromegalyPhase 1NCT06372652

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

A Phase 1 study testing TE-8214 - SAD in people with Acromegaly, run by Immunwork, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Acromegaly
What is being tested?
TE-8214 - SAD
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteAustralia
Study dates
18 Jun 2024to 6 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 gallstones, prior cholecystectomy is not exclusionary.
  • History of B12 deficiency.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX Clinical Research

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

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

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.

Read the 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
Being tested
TE-8214 - SAD, Placebo
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TE-8214 - SADDrug

    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

  • PlaceboDrug

    Single subcutaneous dose of matching placebo across the cohorts

Study groups in NCT06372652
Study groupRoleWhat they receive
SAD CohortExperimentalEach participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional)
Receives: Drug: TE-8214 - SAD
PlaceboExperimentalEach participant will receive matching volume doses of Placebo administered by subcutaneous injection
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

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

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

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

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

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

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

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

    Measured: 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)

  1. PK Parameters: Maximum observed concentration (Cmax)

    Measured: 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

  2. PK Parameters: Time to maximum observed concentration (Tmax)

    Measured: 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

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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start18 Jun 2024
  3. Primary completion10 Oct 2024
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372652
Sponsor's protocol ID
TE-8214-001
Status last verified
May 2025
First submitted
15 Apr 2024
Last updated
20 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu YH, Chuang YS, Gehlert J, Peng CJ, Lin WC, Wong MT, Wright J, Chu HM, Lim C, Chang TW. A long-acting octreotide analog formed by conjugation with a peptide linker modified with two fatty acids. Front Endocrinol (Lausanne). 2026 Aug 25;17:1871977. doi: 10.3389/fendo.2026.1871977. eCollection 2026.

    PubMed 42712757

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TE-8214 - SAD in people with Acromegaly, run by Immunwork, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) (time frame: From administration of IP on Day 1 until the EOS/ET visit (Day 84) post dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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