Fibrosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
Interventions
DRUGND-L02-s0201
Specified dose on specified day
Sponsors
Nitto Denko Corporation
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total plasma clearance of drug after IV administration (CL/F) | 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 |
| Apparent first-order terminal elimination half-life (T1/2) | Up to 28 days |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | Up to 28 days |
| Incidence of discontinuations of study drug due to toxicity | Up to 28 days |
| Incidence of adverse events (AEs) | Up to 28 days |
Outcome results
None listed