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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RN0361 | Experimental | subcutaneous injections |
|
| Placebo | Placebo Comparator | calculated volume to match active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RN0361 | Drug | Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in adult healthy subjects. | Phase 1 | Up to Day85 |
| Absolute and percent change from baseline in APOC3 and fasting triglycerides (TG) in subjects with HTG | Phase 2 | Up to Day183 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (PK) parameters (Cmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (Tmax) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. |
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Phase I:
Inclusion Criteria:
Exclusion Criteria:
Phase II:
Inclusion Criteria:
Exclusion Criteria:
Note: Additional inclusion/exclusion ceiteria may apply, per protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TBC Research LLC, | Tamarac | Florida | 33321 | United States | ||
| Versailles Family Medicine / Avacare |
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Phase 1 |
| Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (AUC 0-24) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (t1/2) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (AUC0-inf) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (Vz/F) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Plasma pharmacokinetics (PK) parameters (λz) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to 48 hours post-dose |
| Urine pharmacokinetics (PK) parameters (CLR) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Urine pharmacokinetics (PK) parameters (Aet) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Urine pharmacokinetics (PK) parameters (Aeu) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Urine pharmacokinetics (PK) parameters (FE) of a single ascending SC dose of RN0361 and its metabolite AS3'N-1 in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Absolute and percent change from baseline in APOC3 in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Absolute and percent change from baseline in TG in adult healthy subjects. | Phase 1 | Up to Day 85 |
| Number and incidence of adverse events (AEs)/serious adverse events (SAEs) possibly or probably related to treatment of RN0361 in subjects with HTG. | Phase 2 | Up to Day 183 |
| Absolute and percent change from baseline in remnant cholesterol and VLDL-C in subjects with HTG. | Phase 2 | Up to Day 183 |
| Versailles |
| Kentucky |
| 40383 |
| United States |
| Axis Clinicals USA | Dilworth | Minnesota | 56529 | United States |
| Synergy Groups Medical | Houston | Texas | 77061 | United States |
| Tranquil | Webster | Texas | 77598 | United States |
| Ogden Clinic, Mountain View / Avacare | Pleasant View | Utah | 84404 | United States |
| University of the Sunshine Coast Clinical Trials | Morayfield | Queensland | Australia |
| University of the Sunshine Coast Clinical Trials, Sippy Downs | Sippy Downs | Queensland | 4556 | Australia |
| Altona Clinical Research | Altona N. | Victoria | 3025 | Australia |
| Nucleus Network Melbourne | Melbourne | Victoria | 3004 | Australia |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| C538489 | Familial hyperchylomicronemia syndrome |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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