A Study to Establish Safety and Maximum Tolerated Dose of IV Trehalose in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy Volunteer Subjects

In brief

This will be a double-blind, randomized, placebo-controlled, single ascending dose study performed in healthy subjects. The study will include up to four escalating dose cohorts with eight (8) subjects in each cohort. In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2). All subjects, regardless of their treatment arm assignment, will undergo the same evaluations and will receive the study drug at the clinic. Each subject will continue to be followed for one week post dosing.

Key facts

Study ID

NCT02725957

Run by

Bioblast Pharma Ltd.

People needed

24

Starts

2016-03-01

Expected to finish

2016-08-01

Last updated by the study team

2016-11-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women between 18 and 55 years (inclusive) of age
• Body Mass Index (BMI) 19 to 29.9 kg/m2 (inclusive) and weighing at least 55 kg.
• Subjects in general good health in the opinion of the investigator
• Blood pressure and heart rate within normal limits
• Female subjects must have a negative serum pregnancy test during the Screening period (Day -28 to -1) and be willing and able to use a medically acceptable method of birth control or be postmenopausal.

You may not qualify if…

• Diabetes mellitus type 1 or 2 or HbA1c > 5.6 % at Screening
• History of significant medical disorder
• Any clinically significant abnormality in safety laboratory tests during the Screening period (Day -28 to -1)
• Known contraindication, hypersensitivity and/or allergy to trehalose
• Any acute illness (e.g. acute infection) within 72 hours
• Participation in another clinical trial with drugs received within 3 months prior to dosing
• Positive serum pregnancy test determined during the Screening period or currently lactating women
• ECG with clinically significant finding recorded during the Screening period
• Positive HIV, Hepatitis B or Hepatitis C serology at Screening
• Known history of alcohol or drug abuse in the past 5 years
• Positive urinary drug screen determined during the Screening period

Where it is running

• PAREXEL Baltimore Early Phase Clinical Unit; Harbor Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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