Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124

Healthy Clinical Trial

Official title:

A Phase 1a/1b, Randomized, Double-blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124 After Single and Multiple IV Infusion Dosing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728061
• Other study ID #: GEn1E-1124-001
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2021
• Est. completion date: June 18, 2021

Study information

• Verified date: November 2021
• Source: GEn1E Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 objectives of the study are to assess what the body does to the investigational drug, what the investigational drug does to the body and also to observe the safety and tolerability of the investigational drug healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy male and female subjects;

2. Between 18 and 55 years of age;

3. Provide a signed EC-approved consent form;

4. Generally healthy, in the opinion of the Investigator;

5. Body Mass Index (BMI) 18 to 30 kg/m^2;

6. Creatinine clearance with in specific parameter;

7. Using method of contraception;

8. Willing and able to comply with protocol requirements for the duration of the study.

Exclusion Criteria:

1. Subjects taking prohibited medication;

2. Subjects with a history or presence of clinically significant medical or psychiatric disease;

3. Subjects who have regularly used nicotine-containing products ;

4. Subjects who have used caffeine-containing products;

5. Subjects who are unable to comply with eating a standardized meal during the study;

6. Subjects with a hospital admission or major surgery within 30 days prior to Screening;

7. Subjects with a plasma donation within 7 days prior to Screening;

8. 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;

9. Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;

10. Subjects who are pregnant or breastfeeding

11. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;

12. 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Gen1E-1124
Intravenously-infused Gen1E-1124 in vehicle.
• Placebo
Intravenously-infused vehicle.

Locations

Country	Name	City	State
New Zealand	GEn1E-1124 Clinical Research Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
GEn1E Lifesciences

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events from the start of randomization through the final follow-up visit		Up to 14 days post-dose
Secondary	Plasma levels of GEn1E-1124 and potential metabolites		Through 24 hours post-dose
Secondary	Urine levels of GEn1E-1124 and potential metabolites		Through 24 hours post-dose
Secondary	Cytokines measured in whole blood		Up to 24 hours post-dose
Secondary	Selected biomarkers measured in whole blood		Up to 24 hours post-dose

External Links

•   Sponsor Website