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

Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241264
• Other study ID #: ND-L02-s0201-004
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2017
• Last updated: August 3, 2017
• Start date: August 28, 2016
• Est. completion date: October 21, 2016

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 21, 2016
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis

Intervention

Drug:
• ND-L02-s0201
Specified dose on specified day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	This trial was conducted by the previous sponsor, Nitto Denko Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		Up to 28 days
Primary	Time to maximum plasma concentration (Tmax)		Up to 28 days
Primary	Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)		Up to 28 days
Primary	Area under the plasma concentration-time curve extrapolated to infinity (AUC0-8)		Up to 28 days
Primary	Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)		Up to 28 days
Primary	Apparent first-order terminal elimination rate constant (Kel)		Up to 28 days
Primary	Volume of distribution during the elimination phase after IV administration (Vz)		Up to 28 days
Primary	Apparent volume of distribution at steady-state (Vss)		Up to 28 days
Primary	Total plasma clearance of drug after IV administration (CL/F)		Up to 28 days
Primary	Apparent first-order terminal elimination half-life (T1/2)		Up to 28 days
Secondary	Incidence of adverse events (AEs)		Up to 28 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 28 days
Secondary	Incidence of discontinuations of study drug due to toxicity		Up to 28 days

External Links

•   FDA Safety Alerts and Recalls