NCT04728061

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GEn1E Lifesciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Gen1E-1124	Intravenously-infused Gen1E-1124 in vehicle.
DRUG	Placebo	Intravenously-infused vehicle.

Timeline

• Start date: 2021-01-07
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-01-28
• Last updated: 2021-12-02

Locations

1 site across 1 country: New Zealand