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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
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
Single subcutaneous dose of matching placebo across the cohorts
CMAX Clinical Research
Adelaide, South Australia, Australia
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
Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events
Time frame: 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)
Time frame: 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
Time frame: From Screening until EOS/ET (Day 84) post dose
Safety and tolerability of TE-8214 by the changes in physical examination findings
Time frame: 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
Time frame: At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose
PK Parameters: Maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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)
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Time frame: 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