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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Gen1E-1124; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • GEn1E-1124 Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Ascending Dose	Drug: Gen1E-1124; Intravenously-infused Gen1E-1124 in vehicle.; Drug: Placebo; Intravenously-infused vehicle.
EXPERIMENTAL: Multiple Ascending Dose	Drug: Gen1E-1124; Intravenously-infused Gen1E-1124 in vehicle.; Drug: Placebo; Intravenously-infused vehicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Cytokines measured in whole blood	Up to 24 hours post-dose
Selected biomarkers measured in whole blood	Up to 24 hours post-dose

Collaborators and Investigators

• Sponsor: GEn1E Lifesciences

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2021
• Primary Completion (ACTUAL): June 18, 2021
• Study Completion (ACTUAL): June 18, 2021

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GEn1E-1124-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No