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This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers, enrolled at a single site in the United States to investigate the safety, tolerability, and pharmacokinetics of DSTA4637S.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSTA4637S | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSTA4637S | Drug | Participants will receive DSTA4637S intravenously on Day 1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with at least 1 Adverse Event (AE) | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of analytes of DSTA4637S in plasma and serum | Up to Day 85 | |
| Concentration of anti-therapeutic antibodies (ATA) to DSTA4637S | Up to Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International Clinical Pharmacology Center (EDS US Clinic) | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30910894 | Derived | Peck M, Rothenberg ME, Deng R, Lewin-Koh N, She G, Kamath AV, Carrasco-Triguero M, Saad O, Castro A, Teufel L, Dickerson DS, Leonardelli M, Tavel JA. A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti-Staphylococcus aureus Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers. Antimicrob Agents Chemother. 2019 May 24;63(6):e02588-18. doi: 10.1128/AAC.02588-18. Print 2019 Jun. |
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| Placebo |
| Drug |
Participants will receive placebo matched to DSTA4637S intravenously on Day 1. |
|