A Phase 1 Study of TE-8214 Solution in Healthy Volunteers (NCT06372652) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Study of TE-8214 Solution in Healthy Volunteers
Australia32 participantsStarted 2024-06-18
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs)
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: From Screening until EOS/ET (Day 84) post dose
5
Safety and tolerability of TE-8214 by the changes in physical examination findings
Timeframe: 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
Timeframe: At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose
. 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.