# First-in-human study of two anti-SARS CoV-2 antibodies in health volunteers

> **NIH NIH UM1** · WISTAR INSTITUTE · 2021 · $1,571,599

## Abstract

Project Summary
The Coronavirus Disease 2019 (COVID-19) pandemic is currently gripping the world without a known cure or
prevention. Aside from the health consequences, the necessary decrease in human activity has resulted in
economic losses without modern precedent, especially in the developing world where health care and sanitation
were not sufficient even prior to the pandemic. Innumerable efforts are being undertaken to develop vaccines to
SARS-CoV-2 and it is likely that antibodies will be essential for protection.
COVID-19 antibody therapy in the form of polyclonal plasma from convalescent individuals is currently being
explored as a therapeutic option and has been granted an emergency use authorization (EUA) by the FDA.
Monoclonal antibodies may prove to be particularly useful in preventing SARS-CoV-2 infection in populations
who may not mount protective immune responses to vaccination (e.g. advanced age, immunocompromise) and
for post-exposure prophylaxis in individuals at high risk to develop severe COVID-19.
C135 and C144 are recombinant, fully human mAbs that specifically bind SARS-CoV-2 spike protein receptor
binding domain (RBD) and exhibit exceptional neutralizing activity in vitro against SARS-CoV-2. Two one-amino
acid mutations have been introduced to prolong half-life and allow dose sparing. The C135-LS and C144-LS
combination has shown remarkable activity in both prophylaxis and therapy experiments in several relevant
animal models in both prophylaxis and treatment experiments. These preclinical data support the clinical evahe
from SARS-CoV-2 and accelerate viral clearance and disease resolution in SARS-CoV-2-infected individuals.
The proposed study is a first-in-human, open label, single dose, dose-escalation phase 1 trial to evaluate the
safety and pharmacokinetics of the C135-LS and C144-LS combination in healthy volunteers.

## Key facts

- **NIH application ID:** 10291661
- **Project number:** 3UM1AI126620-05S1
- **Recipient organization:** WISTAR INSTITUTE
- **Principal Investigator:** Luis J Montaner
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,571,599
- **Award type:** 3
- **Project period:** 2021-02-23 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10291661

## Citation

> US National Institutes of Health, RePORTER application 10291661, First-in-human study of two anti-SARS CoV-2 antibodies in health volunteers (3UM1AI126620-05S1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10291661. Licensed CC0.

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