Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124

Study Overview
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Brief Summary
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In this early phase clinical research study, the investigational drug will be administered to 64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center. The objectives of the study are to assess what the body does to the investigational drug, what the investigational drug does to the body and also to observe the safety and tolerability of the investigational drug healthy volunteers.

Official Title
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A Phase 1a/1b, Randomized, Double-blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124 After Single and Multiple IV Infusion Dosing in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gen1E-1124
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects; Between 18 and 55 years of age; Provide a signed EC-approved consent form; Generally healthy, in the opinion of the Investigator; Body Mass Index (BMI) 18 to 30 kg/m^2; Creatinine clearance with in specific parameter; Using method of contraception; Willing and able to comply with protocol requirements for the duration of the study. Exclusion Criteria: Subjects taking prohibited medication; Subjects with a history or presence of clinically significant medical or psychiatric disease; Subjects who have regularly used nicotine-containing products ; Subjects who have used caffeine-containing products; Subjects who are unable to comply with eating a standardized meal during the study; Subjects with a hospital admission or major surgery within 30 days prior to Screening; Subjects with a plasma donation within 7 days prior to Screening; Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit; Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit; Subjects who are pregnant or breastfeeding Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening; Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose<br> | Drug: Gen1E-1124<br>* Intravenously-infused Gen1E-1124 in vehicle.<br>Drug: Placebo<br>* Intravenously-infused vehicle.<br>|
| Experimental: Multiple Ascending Dose<br> | Drug: Gen1E-1124<br>* Intravenously-infused Gen1E-1124 in vehicle.<br>Drug: Placebo<br>* Intravenously-infused vehicle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events from the start of randomization through the final follow-up visit |  | Up to 14 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of GEn1E-1124 and potential metabolites |  | Through 24 hours post-dose | 
| Urine levels of GEn1E-1124 and potential metabolites |  | Through 24 hours post-dose | 
| Cytokines measured in whole blood |  | Up to 24 hours post-dose | 
| Selected biomarkers measured in whole blood |  | Up to 24 hours post-dose |