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

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

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

Study Overview

• Status: Completed
• Conditions: Fibrosis
• Intervention / Treatment: Drug: ND-L02-s0201

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Nitto Denko Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2016
• Primary Completion (Actual): October 21, 2016
• Study Completion (Actual): October 21, 2016

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: ND-L02-s0201-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No