RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (RU)

August 2, 2022 updated by: Rockefeller University

A Phase 1, Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of a Combination of Two Anti-SARS-CoV-2 mAbs (C144-LS and C135-LS) in Healthy Volunteers

This is a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has a standard 3+3 phase 1 dose escalation design. Study participants will receive subcutaneous injections of C144-LS and C135-LS at 4ml (approximately 100mg of each antibody administered separately) or 8ml (approximately 200mg of each antibody administered separately), or sequential intravenous infusions of C144-LS and C135-LS, at one of three increasing dose levels (1.5 mg/kg, 5 mg/kg and 15 mg/kg of each antibody).

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • The Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 or older.
  • If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration.

Exclusion Criteria:

  • Weight > 110 kg for groups S1 and S2 only
  • History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology.
  • Active respiratory or non-respiratory symptoms consistent with COVID-19.
  • Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening.
  • Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening.
  • Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
  • Other clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.

  • Laboratory abnormalities in the parameters listed:

    • Absolute neutrophil count less than 1,500 K/mcL;
    • Hemoglobin less than 10.5 gm/dL if female; less than 11 gm/dL if male;
    • Platelet count less than 125,000 K/mcL;
    • ALT less than 1.25 x ULN; AST less than 1.25 x ULN;
    • Total bilirubin less than 1.25 x ULN;
    • Creatinine less than 1.1 x ULN;
  • Pregnancy or lactation.
  • Any vaccination within 14 days prior to SARS-CoV-2 mAbs administration (except influenza vaccine).
  • History of prior receipt of any SARS-CoV-2 vaccine or antibodies, including convalescent plasma.
  • Known allergy/sensitivity or any hypersensitivity to components of the investigational agents.
  • History of severe reaction to a vaccine or monoclonal antibody administration or history of severe allergic reactions.
  • Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S1 - low dose
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
Biological: C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
Experimental: S2 - mid dose
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
Biological: C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
Experimental: V1 - low dose
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
Biological: C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
Experimental: V2 - mid dose
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
Biological: C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
Experimental: V3 - high dose
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
Biological: C144-LS and C-135-LS
A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 2 and higher adverse events 4 weeks after administration.
Time Frame: 4 weeks
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
4 weeks
Grade 3 and higher adverse events 4 weeks after administration.
Time Frame: 4 weeks
The number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).
4 weeks
Related Serious adverse events (SAEs) throughout the study period
Time Frame: 48 weeks
The number of participants with treatment-related solicited serious adverse events.
48 weeks
Elimination half-life (t1/2) of C135-LS and C144-LS
Time Frame: 48 weeks
Half-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
48 weeks
Clearance rate of C135-LS and C144-LS
Time Frame: 48 weeks
Clearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
48 weeks
Area under the curve of C135-LS and C144-LS
Time Frame: 48 weeks
Area under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigational product (IP)-related adverse events during study follow up.
Time Frame: 48 weeks
The number of participants with treatment-related adverse events
48 weeks
Anti-C144-LS and anti-C135-LS antibodies in all study groups.
Time Frame: 48 weeks
Proportion of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response
48 weeks
Serum neutralizing activity against SARS-CoV-2
Time Frame: 48 weeks
Serum neutralizing activity against SARS-CoV-2 following C144-LS and C135-LS administration
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

  • Principal Investigator: Christian Gaebler, MD, The Rockefeller University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Actual)

February 2, 2022

Study Completion (Actual)

February 2, 2022

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUCOV1
  • CGA-1015 (Other Identifier: Rockefeller University IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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