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This first-in-human study is a randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose study of SL-325 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD: SL-325 | Experimental | Participants will receive a single dose of SL-325 in escalating dose cohorts |
|
| SAD: Placebo | Placebo Comparator | Participants will receive a single dose of placebo (normal saline) |
|
| MAD: SL-325 | Experimental | Participants will receive a three doses of SL-325 in escalating dose cohorts |
|
| MAD: Placebo | Placebo Comparator | Participants will receive a three doses of placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL-325 | Biological | DR3 blocking antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of treatment-emergent adverse events | Day 1 through 75 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Cmax | Maximum observed concentration | Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): Tmax | Time at which the maximum concentration is observed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C557621 | 3-(2-(4-quinolin-3-yl)benzyl-1-oxoisoindolin-6-yl)-N-hydroxy-acrylamide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo (Normal Saline) |
| Other |
Normal saline |
|
| Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): Ctrough | Minimum observed concentration following a single dose | Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): AUC | Area under the concentration-time curve | Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): T1/2 | Terminal elimination half-life | Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): CL | Clearance | Day 1 through 75 days after last dose |
| Pharmacokinetics (PK): Vz | Volume of distribution | Day 1 through 75 days after last dose |
| Immunogenicity: Number/proportion of participants with positive or negative anti-drug antibody (ADA) titers | Day 1 through 75 days after last dose |
| Immunogenicity: Number/proportion of participants with neutralizing anti-drug antibodies | Day 1 through 75 days after last dose |
| Immunogenicity: Time to onset and duration of anti-drug antibodies | Day 1 through 75 days after last dose |
| Immunogenicity: Number/proportion of participants with transient vs persistent anti-drug antibodies | Day 1 through 75 days after last dose |
| Receptor Occupancy: Percent of DR3-positive T cells bound by SL-325 | Day 1 through 75 days after last dose |
| Receptor Occupancy: Duration of DR3-positive T cell binding by SL-325 | Day 1 through 75 days after last dose |