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 range18 Years – 64 Years

SexALL

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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.
✕. 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.

What they're measuring

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

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

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

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

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

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

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

Trial details

NCT IDNCT06372652

SponsorImmunwork, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-10

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