Study to Assess the Pharmacokinetics, Pharmacodynamics, S... | NCT04728061

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

NCT04728061

Sponsor

GEn1E Lifesciences

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Gen1E-1124
Placebo

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

Jun 18, 2021Actual

Completion Date

Jun 18, 2021Actual

First Submitted Date

Jan 22, 2021

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2021

Last Update Posted Date

Dec 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Ascending Dose	Experimental		Drug: Gen1E-1124 Drug: Placebo
Multiple Ascending Dose	Experimental		Drug: Gen1E-1124 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gen1E-1124	Drug	Intravenously-infused Gen1E-1124 in vehicle.	Multiple Ascending Dose Single Ascending Dose

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided