A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body

Official Title
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A Phase 1, Open-Label, Randomized-Sequence, Single-Crossover, Bridging Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Two ND-L02-s0201 Formulations, Frozen Versus Lyophilized, Administered by Intravenous Infusion to Healthy Male and Female Subjects

Conditions
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Fibrosis

Intervention / Treatment
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* Drug: ND-L02-s0201


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health, as determined by the Investigator Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug Subject has serum calcium and parathyroid hormone (intact) within the limits of the normal range of the laboratory Exclusion Criteria: Subject has a disease or condition (medical or surgical) which, in the opinion of the Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201 solution, or that may place the subject at increased risk Subject has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma Subject has abnormal laboratory values considered to be clinically significant by the Investigator Other protocol inclusion/exclusion criteria may apply

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Module A<br>Lyophilized Formulation | Drug: ND-L02-s0201<br>* Specified dose on specified day<br>|
| Experimental: Module B<br>Frozen Formulation | Drug: ND-L02-s0201<br>* Specified dose on specified day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Up to 28 days | 
| Time to maximum plasma concentration (Tmax) |  | Up to 28 days | 
| Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t) |  | Up to 28 days | 
| Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) |  | Up to 28 days | 
| Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf) |  | Up to 28 days | 
| Apparent first-order terminal elimination rate constant (Kel) |  | Up to 28 days | 
| Volume of distribution during the elimination phase after IV administration (Vz) |  | Up to 28 days | 
| Apparent volume of distribution at steady-state (Vss) |  | Up to 28 days | 
| Total plasma clearance of drug after IV administration (CL/F) |  | Up to 28 days | 
| Apparent first-order terminal elimination half-life (T1/2) |  | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to 28 days | 
| Incidence of serious adverse events (SAEs) |  | Up to 28 days | 
| Incidence of discontinuations of study drug due to toxicity |  | Up to 28 days |