Trials / Terminated
TerminatedNCT04883138
Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients
A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- GigaGen, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.
Detailed description
This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19. Participants will receive a single intravenous (IV) infusion dose of GIGA-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (Day 56).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GIGA-2050 | Recombinant Hyperimmune Polyclonal Antibody |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2022-01-11
- Completion
- 2022-01-11
- First posted
- 2021-05-12
- Last updated
- 2022-01-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04883138. Inclusion in this directory is not an endorsement.