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

Phase 1

Completed

• Conditions: Fibrosis
• Interventions: Drug: ND-L02-s0201

• Registration Number: NCT03241264
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-28
• Primary Completion: 2016-10-21
• Study Completion: 2016-10-21
• Status Verified: 2017-07
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Module A	ND-L02-s0201	Lyophilized Formulation
Module B	ND-L02-s0201	Frozen Formulation

Primary Outcome Measures

Name	Time	Method
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
Time to maximum plasma concentration (Tmax)	Up to 28 days
Maximum plasma concentration (Cmax)	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
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
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
Total plasma clearance of drug after IV administration (CL/F)	Up to 28 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to 28 days
Incidence of discontinuations of study drug due to toxicity	Up to 28 days
Incidence of serious adverse events (SAEs)	Up to 28 days