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Completed

NCT Number: NCT03241264

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

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

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Key information

Conditions

Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ND-L02-s0201

Drug

Specified dose on specified day

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 28 days

  2. Time to maximum plasma concentration (Tmax)

    Time frame: Up to 28 days

  3. Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)

    Time frame: Up to 28 days

  4. Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)

    Time frame: Up to 28 days

  5. Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)

    Time frame: Up to 28 days

  6. Apparent first-order terminal elimination rate constant (Kel)

    Time frame: Up to 28 days

  7. Volume of distribution during the elimination phase after IV administration (Vz)

    Time frame: Up to 28 days

  8. Apparent volume of distribution at steady-state (Vss)

    Time frame: Up to 28 days

  9. Total plasma clearance of drug after IV administration (CL/F)

    Time frame: Up to 28 days

  10. Apparent first-order terminal elimination half-life (T1/2)

    Time frame: Up to 28 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 28 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 28 days

  3. Incidence of discontinuations of study drug due to toxicity

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Nitto Denko Corporation

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2017
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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