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

Sponsor
GEn1E Lifesciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04728061
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 7, 2021
Actual Primary Completion Date :
Jun 18, 2021
Actual Study Completion Date :
Jun 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Plasma levels of GEn1E-1124 and potential metabolites [Through 24 hours post-dose]

  2. Urine levels of GEn1E-1124 and potential metabolites [Through 24 hours post-dose]

  3. Cytokines measured in whole blood [Up to 24 hours post-dose]

  4. Selected biomarkers measured in whole blood [Up to 24 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GEn1E-1124 Clinical Research Site Christchurch New Zealand 8011

Sponsors and Collaborators

  • GEn1E Lifesciences

Investigators

  • Study Director: Ritu Lal, PhD, MS, GEn1E Lifesciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GEn1E Lifesciences
ClinicalTrials.gov Identifier:
NCT04728061
Other Study ID Numbers:
  • GEn1E-1124-001
First Posted:
Jan 28, 2021
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 2, 2021