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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Fibrosis

Treatments: Drug: ND-L02-s0201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03241264

ND-L02-s0201-004

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Module A

Experimental group

Description:

Lyophilized Formulation

Treatment:

Drug: ND-L02-s0201

Module B

Experimental group

Description:

Frozen Formulation

Treatment:

Drug: ND-L02-s0201