Status:
COMPLETED
Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124
Lead Sponsor:
GEn1E Lifesciences
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
In this early phase clinical research study, the investigational drug will be administered to 64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center. The objectiv...
Eligibility Criteria
Inclusion
- Healthy male and female subjects;
- Between 18 and 55 years of age;
- Provide a signed EC-approved consent form;
- Generally healthy, in the opinion of the Investigator;
- Body Mass Index (BMI) 18 to 30 kg/m\^2;
- Creatinine clearance with in specific parameter;
- Using method of contraception;
- Willing and able to comply with protocol requirements for the duration of the study.
Exclusion
- Subjects taking prohibited medication;
- Subjects with a history or presence of clinically significant medical or psychiatric disease;
- Subjects who have regularly used nicotine-containing products ;
- Subjects who have used caffeine-containing products;
- Subjects who are unable to comply with eating a standardized meal during the study;
- Subjects with a hospital admission or major surgery within 30 days prior to Screening;
- Subjects with a plasma donation within 7 days prior to Screening;
- Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit;
- Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
- Subjects who are pregnant or breastfeeding
- Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
- Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04728061
Start Date
January 7 2021
End Date
June 18 2021
Last Update
December 2 2021
Active Locations (1)
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1
GEn1E-1124 Clinical Research Site
Christchurch, New Zealand, 8011