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First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose of MT-201 | Experimental | To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201 |
|
| Multiple Ascending Dose of MT-201 | Experimental | To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201 |
|
| Single Ascending Dose Placebo Arm | Placebo Comparator | To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo |
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| Multiple Ascending Dose Placebo | Placebo Comparator | To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-201 | Drug | MT-201 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with non-SAEs and SAES | Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities. | Up to 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
male and female (of non-childbearing potential only)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll-Free Number | Contact | 844-206-4980 | clinicaltrials@miradortx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mirador Clinical Department, San Diego, California 92121 | Recruiting | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| C460839 | adecatumumab |
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Double-Blind
| Placebo |
| Drug |
Placebo |
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