NCT04582318

A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19

A Randomized, Double Blind, Placebo Controlled, Combined Phase 1/2 Single Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of NGM621 in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Subjects With Confirmed SARS-CoV-2 Infection

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: NGM Biopharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	NGM621	NGM621 will be administered via IV infusion
BIOLOGICAL	Placebo	Placebo will be administered via IV infusion

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-02-18
• Completion: 2021-03-11
• First posted: 2020-10-09
• Last updated: 2022-02-25

Locations

1 site across 1 country: Australia