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

NCT04728061 | Completed Phase 1

• 1 other identifier: GEn1E-1124-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events from the start of randomization through the final follow-up visit

  Up to 14 days post-dose

Secondary Outcomes (4)

• 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

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Drug: Gen1E-1124; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

Drug: Gen1E-1124; Drug: Placebo

Interventions

Gen1E-1124 DRUG

Intravenously-infused Gen1E-1124 in vehicle.

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

Intravenously-infused vehicle.

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GEn1E Lifesciences: lead

Study Sites (1)

GEn1E-1124 Clinical Research Site

Christchurch, 8011, New Zealand

Location

Related Links

• Sponsor Website

Study Officials

• Ritu Lal, PhD, MS

  GEn1E Lifesciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 28, 2021
• Study Start: January 7, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)