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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700163
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE January 7, 2021
Last Update Posted Date August 4, 2022
Actual Study Start Date  ICMJE January 11, 2021
Actual Primary Completion Date February 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
  • 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).
  • 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).
  • Related Serious adverse events (SAEs) throughout the study period [ Time Frame: 48 weeks ]
    The number of participants with treatment-related solicited serious adverse events.
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
  • Investigational product (IP)-related adverse events during study follow up. [ Time Frame: 48 weeks ]
    The number of participants with treatment-related adverse events
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: S1 - low dose
    100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
    Intervention: Biological: C144-LS and C-135-LS
  • Experimental: S2 - mid dose
    200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
    Intervention: Biological: C144-LS and C-135-LS
  • Experimental: V1 - low dose
    1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
    Intervention: Biological: C144-LS and C-135-LS
  • Experimental: V2 - mid dose
    5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
    Intervention: Biological: C144-LS and C-135-LS
  • Experimental: V3 - high dose
    15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
    Intervention: Biological: C144-LS and C-135-LS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2021)
23
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2021)
15
Actual Study Completion Date  ICMJE February 2, 2022
Actual Primary Completion Date February 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04700163
Other Study ID Numbers  ICMJE RUCOV1
CGA-1015 ( Other Identifier: Rockefeller University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rockefeller University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rockefeller University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Gaebler, MD The Rockefeller University
PRS Account Rockefeller University
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP