MedDataX Logo

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

NCT ID: NCT04728061

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2021-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Ascending Dose

Group Type EXPERIMENTAL

Gen1E-1124

Intervention Type DRUG

Intravenously-infused Gen1E-1124 in vehicle.

Placebo

Intervention Type DRUG

Intravenously-infused vehicle.

Multiple Ascending Dose

Group Type EXPERIMENTAL

Gen1E-1124

Intervention Type DRUG

Intravenously-infused Gen1E-1124 in vehicle.

Placebo

Intervention Type DRUG

Intravenously-infused vehicle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gen1E-1124

Intravenously-infused Gen1E-1124 in vehicle.

Intervention Type DRUG

Placebo

Intravenously-infused vehicle.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GEn1E Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ritu Lal, PhD, MS

Role: STUDY_DIRECTOR

GEn1E Lifesciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GEn1E-1124 Clinical Research Site

Christchurch, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

New Zealand

Related Links

Access external resources that provide additional context or updates about the study.

https://www.gen1elifesci.com/

Sponsor Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GEn1E-1124-001

Identifier Type: -

Identifier Source: org_study_id