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.
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
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.
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- 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.
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 group | Role | What they receive |
|---|---|---|
| SAD Cohort | Experimental | Each participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional) Receives: Drug: TE-8214 - SAD |
| Placebo | Experimental | Each 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.
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
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
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
Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings
Measured: From Screening until EOS/ET (Day 84) post dose
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
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)
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
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
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.
- First posted18 Apr 2024
- Study start18 Jun 2024
- Primary completion10 Oct 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Immunwork, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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