Status:
COMPLETED
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Nitto Denko Corporation
Conditions:
Fibrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03241264
Start Date
August 28 2016
End Date
October 21 2016
Last Update
August 7 2017
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