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

NCT04728061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-12-02

No results posted yet for this study

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

Interventions

DRUG

Gen1E-1124

Intravenously-infused Gen1E-1124 in vehicle.

DRUG

Placebo

Intravenously-infused vehicle.

Sponsors & Collaborators

  • GEn1E Lifesciences

    lead INDUSTRY

Principal Investigators

  • Ritu Lal, PhD, MS · GEn1E Lifesciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2021-06-18
Completion
2021-06-18

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728061 on ClinicalTrials.gov