Recruitment

Recruitment Status
Completed

Inclusion Criterias

Healthy adult male and/or females, 19 to 60 years of age, inclusive.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
...
Healthy adult male and/or females, 19 to 60 years of age, inclusive.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI.
Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.

Exclusion Criterias

Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
...
Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
Participation in another clinical trial within 28 days prior to dosing. The 28-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of Period 1 of the current study.
Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
Blood donation or significant blood loss within 56 days prior to dosing.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
QTc interval >430 msec for males or >450 msec for females, or history of prolonged QT syndrome.
Hemoglobin level below the lower limit of normal at screening or check-in.
Plasma donation within 7 days prior to dosing.
Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
Estimated creatinine clearance < 90 ml/min at screening or check-in.

Summary

Conditions
Healthy Adult Subjects
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Other

Participation Requirements

Age
Between 19 years and 60 years
Gender
Both males and females

Description

This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will ...

This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will participate in only one cohort. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and PK assessment of GMI-1271.

Inclusion Criterias

Healthy adult male and/or females, 19 to 60 years of age, inclusive.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
...
Healthy adult male and/or females, 19 to 60 years of age, inclusive.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI.
Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.

Exclusion Criterias

Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
...
Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
Participation in another clinical trial within 28 days prior to dosing. The 28-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of Period 1 of the current study.
Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
Blood donation or significant blood loss within 56 days prior to dosing.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
QTc interval >430 msec for males or >450 msec for females, or history of prolonged QT syndrome.
Hemoglobin level below the lower limit of normal at screening or check-in.
Plasma donation within 7 days prior to dosing.
Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
Estimated creatinine clearance < 90 ml/min at screening or check-in.

Locations

Lincoln, Nebraska, 68502
Lincoln, Nebraska, 68502

Tracking Information

NCT #
NCT02168595
Collaborators
Not Provided
Investigators
  • Principal Investigator: Barbara Cook, MD Celerion
  • Barbara Cook, MD Celerion