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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-28

Study Completion Date

2016-10-21

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

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Detailed Description

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Conditions

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Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Module A

Lyophilized Formulation

Group Type EXPERIMENTAL

ND-L02-s0201

Intervention Type DRUG

Specified dose on specified day

Module B

Frozen Formulation

Group Type EXPERIMENTAL

ND-L02-s0201

Intervention Type DRUG

Specified dose on specified day

Interventions

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ND-L02-s0201

Specified dose on specified day

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes