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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04582318
• Other study ID #: 621-CP-102
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 9, 2020
• Est. completion date: March 11, 2021

Study information

• Verified date: February 2022
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 11, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result prior to dosing.

• Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must use an effective method of contraception during the study, for at least 1 month following study completion, and must not plan to become pregnant for at least 1 month after her last study medication dose.

• BMI 18-32 kg/m2 inclusive

• Ability to understand and provide informed consent

• Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized

• If on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation

Exclusion Criteria:

• Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection

• Known history of complement deficiency

• Active infection with, or history of, compllicated pneumococcal or Neisseria meningitis infection or history of unexplained, recurrent infection, within the last 60 days prior to dosing.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Biological:
• NGM621
NGM621 will be administered via IV infusion
• Placebo
Placebo will be administered via IV infusion

Locations

Country	Name	City	State
Australia	NGM Clinical Study Site	Brisbane

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events - Part 1	TEAEs in subjects receiving NGM621 compared to placebo	85 days
Primary	Treatment emergent adverse events - Part 2	TEAEs in subjects receiving NGM621 compared to placebo	91 days
Primary	Clinical status at Day 15 and Day 29 - Part 2	Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group	29 days
Secondary	Maxiumum Serum Concentration [Cmax]		91 days
Secondary	Mortality at Day 29		29 days
Secondary	Duration of Supplemental Oxygen Requirement		91 days
Secondary	Change in Hemolytic Assays (CH50 and AH50) from Baseline		91 days