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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort | Experimental | Each participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional) |
|
| Placebo | Experimental | Each participant will receive matching volume doses of Placebo administered by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TE-8214 - SAD | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) | 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 | 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) | 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 | From Screening until EOS/ET (Day 84) post dose | |
| Safety and tolerability of TE-8214 by the changes in physical examination findings | 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 | At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters: Maximum observed concentration (Cmax) | 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| Placebo | Drug | Single subcutaneous dose of matching placebo across the cohorts |
|
| PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last) | 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 |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |