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

NCT03241264 | Completed Phase 1 FDA Drug

• 1 other identifier: ND-L02-s0201-004
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fibrosis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• 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

Study Arms (2)

Module A

EXPERIMENTAL

Lyophilized Formulation

Drug: ND-L02-s0201

Module B

EXPERIMENTAL

Frozen Formulation

Drug: ND-L02-s0201

Interventions

ND-L02-s0201 DRUG

Specified dose on specified day

Module A; Module B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Nitto Denko Corporation: collaborator

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 7, 2017
• Study Start: August 28, 2016
• Primary Completion: October 21, 2016
• Study Completion: October 21, 2016
• Last Updated: August 7, 2017

Record last verified: 2017-07