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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Gen1E-1124; Drug: Placebo

• Registration Number: NCT04728061
• Lead Sponsor: GEn1E Lifesciences

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Dose	Placebo	-
Multiple Ascending Dose	Gen1E-1124	-
Single Ascending Dose	Placebo	-
Single Ascending Dose	Gen1E-1124	-

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events from the start of randomization through the final follow-up visit	Up to 14 days post-dose

Secondary Outcome Measures

Name	Time	Method
Plasma levels of GEn1E-1124 and potential metabolites	Through 24 hours post-dose
Urine levels of GEn1E-1124 and potential metabolites	Through 24 hours post-dose
Selected biomarkers measured in whole blood	Up to 24 hours post-dose
Cytokines measured in whole blood	Up to 24 hours post-dose

Trial Locations

Locations (1)

GEn1E-1124 Clinical Research Site; 🇳🇿 Christchurch, New Zealand