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The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.
Other exploratory objectives are:
To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose Cohorts 1-6 | Experimental | Drug: VLX-1005 |
|
| Single Ascending Dose Cohorts 1-6, Placebo | Placebo Comparator | Drug: Placebo |
|
| Multiple Ascending Dose Cohorts 7-9 | Experimental | Drug: VLX-1005 |
|
| Multiple Ascending Dose Cohorts 7-9, Placebo | Placebo Comparator | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLX-1005 | Drug | VLX-1005 infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events | Baseline up to Day 29 | |
| Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Baseline up to Day 29 | |
| Number of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) or Telemetry Parameters at Least Once Post Dose | Baseline up to Day 29 | |
| Number of Participants Who Meet the Markedly Abnormal Criteria for Laboratory Values at Least Once Post Dose | Baseline up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(inf) | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for VLX-1005 | day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion |
| C(max) | Plasma Concentration at the end of Infusion for VLX-1005 |
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Inclusion Criteria:
Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
Body weight ≥ 50 kg at the screening visit.
Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
Has laboratory values (clinical chemistry and hematology) within the normal reference range. Deviations from this range may be acceptable if they are considered 'not clinically significant' (NCS) by the PI.
Males who have not been vasectomized participating in the study must agree to use at least 2 approved methods of contraception (ie double-barrier or barrier plus hormonal), or abstain from sexual intercourse, from Day -2 to 4 weeks after dosing (or last dose Parts B)
Is a non-smoker and must not have used any nicotine products within three months prior to screening.
Able and willing to attend the necessary visits to the study center.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Hunt, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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| Placebo | Drug | Placebo infusion |
|
| day 1 at the end of infusion (1 hour after infusion starts) |
| T1/2 | Terminal Disposition Phase Half-life for VLX-1005 | day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion |
| Pharmacodynamics of 12-Lipoxygenase Inhibition | 12-HETE measurement in serum | day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion |