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It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose of TB001 | Experimental | In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
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| Multiple-dose of TB001 | Experimental | In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
|
| Single-dose of placebo | Placebo Comparator | In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1. |
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| Multiple-dose of placebo | Placebo Comparator | In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB001 | Drug | once-daily subcutaneous injection, on Day 1 in SAD stage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. | Day 1 and up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics exposure of TB001 in SAD and MAD stage | Serum concentrations of TB001 at different timepoints before and after TB001 administration. | Day 1 , Day 7 |
| Observed immunogenicity of TB001 in MAD stage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Turier Biotech Co., Ltd. | Shenzhen | Guangdong | 518122 | China |
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| TB001 |
| Drug |
once-daily subcutaneous injection, on Days 1-7 in MAD stage |
|
| Placebo | Drug | once-daily subcutaneous injection, on Day 1 in SAD stage |
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| Placebo | Drug | once-daily subcutaneous injection, on Days 1-7 in MAD stage |
|
Number of subjects who develop detectable ADAs and NAb after TB001 administration.
| Day 1, Day 7, Day 14, Day 28 |