A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes
NCT Number: NCT06471530
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight and Obesity
Interventions: DRUG: TE-8105 SAD Cohort 1|DRUG: TE-8105 SAD Cohort 2|DRUG: TE-8105 SAD Cohort 3|DRUG: TE-8105 SAD Cohort 4|DRUG: TE-8105 SAD Cohort 5 (Adaptive cohort)|DRUG: TE-8105 MAD Cohort 1|DRUG: TE-8105 MAD Cohort 2
Sponsor: Immunwork, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-10-25
Locations: CMAX Clinical Research, Adelaide, South Australia, 5000, Australia

Summary:
This is a Phase 1, first-in-human, prospective, open-label study to evaluate the safety, tolerability, PK, and PD of TE-8105 in overweight/obese participants without diabetes. Study TE-8105-101 consists of 2 parts: Part A (single-ascending dose \[SAD\]) and Part B (multiple-ascending dose \[MAD\]).

Primary Outcome Measures: Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events, SAD: From Screening until Day 43 (End of study) post dose. MAD: From Screening until Day 134 (End of study) post dose|Safety and tolerability of TE-8105 by the incidence of injection site reactions (ISRs), SAD: On Day 1, Day 2, Day 3, Day 5, Day 8. MAD: On Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64 post dose|Number of participants with change in serum blood parameters, Laboratory assessment includes Hematology, coagulation and serum chemistry., SAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose|Number of participants with change in urine parameters, Laboratory assessment includes urinalysis, SAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose|Number of participants with changes in the physical examination findings, Complete physical examinations include: general appearance, head, ears, eyes, nose, throat, neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, and other., SAD: At screening, Day -1, Day 3, Day 8, Day 15 and Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose|Number of participants with changes in 12 lead ECG findings, ECG measurements to include Heart rate, PR, QRS, QT, and QTcF intervals., SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose|Number of participants with changes in temperature, SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]|Number of participants with changes in blood pressure (BP), Systolic and diastolic BP will be measured, SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]|Number of participants with changes in heart rate (HR), SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]|Number of participants with changes in respiratory rate (RR), SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]
Secondary Outcome Measures: PK Parameters : Maximum observed concentration (Cmax), SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)|PK Parameters : Maximum observed concentration (Cmax), MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)|PK Parameters : Time to maximum observed concentration (Tmax), SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)|PK Parameters : Time to maximum observed concentration (Tmax), MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)|PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last), SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8. Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)|PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last), MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)|PK Parameters : Minimum observed concentration (Cmin), MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)|PK Parameters : AUC over a dosing interval (AUCτ)., MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)