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First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-701 in healthy participants.
This is a first-in-human study of MT-701, a biologic therapy. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-701 in healthy participants. The data obtained from this study will inform further development of MT-701.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1- Single Ascending Dose | Experimental | To assess the safety and tolerability of single intravenous/subcutaneous dose of MT-701. |
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| Part 2- Multiple Ascending Dose | Experimental | To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-701. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-701 | Drug | MT-701 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with non-SAEs and SAES | Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities. | Up to 14 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
Male and female (of non-childbearing potential only)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mirador Clinical Department | San Diego | California | 92121 | United States |
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Double-Blind