NCT04700163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jan 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

January 5, 2021

Results QC Date

April 5, 2023

Last Update Submit

March 6, 2025

Conditions

Covid19

Keywords

Monoclonal antibodySARS-CoV-2

Outcome Measures

Primary Outcomes (6)

  • Grade 2 and Higher Adverse Events 4 Weeks After Administration.

    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.

    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

    The number of participants with treatment-related solicited serious adverse events.

    48 weeks

  • Elimination Half-life (t1/2) of C135-LS and C144-LS

    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

    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

    Area under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers

    48 weeks

Secondary Outcomes (2)

  • Investigational Product (IP)-Related Adverse Events During Study Follow up.

    48 weeks

  • Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.

    48 weeks

Study Arms (5)

S1 - low dose

EXPERIMENTAL

100 mg of C144-LS and 100 mg of C135-LS, subcutaneously

Biological: C144-LS and C-135-LS

S2 - mid dose

EXPERIMENTAL

200 mg of C144-LS and 200 mg of C135-LS, subcutaneously

Biological: C144-LS and C-135-LS

V1 - low dose

EXPERIMENTAL

1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously

Biological: C144-LS and C-135-LS

V2 - mid dose

EXPERIMENTAL

5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously

Biological: C144-LS and C-135-LS

V3 - high dose

EXPERIMENTAL

15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously

Biological: C144-LS and C-135-LS

Interventions

C144-LS and C-135-LSBIOLOGICAL

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

S1 - low doseS2 - mid doseV1 - low doseV2 - mid doseV3 - high dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (5)

  • Schafer A, Muecksch F, Lorenzi JCC, Leist SR, Cipolla M, Bournazos S, Schmidt F, Maison RM, Gazumyan A, Martinez DR, Baric RS, Robbiani DF, Hatziioannou T, Ravetch JV, Bieniasz PD, Bowen RA, Nussenzweig MC, Sheahan TP. Antibody potency, effector function, and combinations in protection and therapy for SARS-CoV-2 infection in vivo. J Exp Med. 2021 Mar 1;218(3):e20201993. doi: 10.1084/jem.20201993.

    PMID: 33211088BACKGROUND

  • Weisblum Y, Schmidt F, Zhang F, DaSilva J, Poston D, Lorenzi JC, Muecksch F, Rutkowska M, Hoffmann HH, Michailidis E, Gaebler C, Agudelo M, Cho A, Wang Z, Gazumyan A, Cipolla M, Luchsinger L, Hillyer CD, Caskey M, Robbiani DF, Rice CM, Nussenzweig MC, Hatziioannou T, Bieniasz PD. Escape from neutralizing antibodies by SARS-CoV-2 spike protein variants. Elife. 2020 Oct 28;9:e61312. doi: 10.7554/eLife.61312.

    PMID: 33112236BACKGROUND

  • Barnes CO, Jette CA, Abernathy ME, Dam KA, Esswein SR, Gristick HB, Malyutin AG, Sharaf NG, Huey-Tubman KE, Lee YE, Robbiani DF, Nussenzweig MC, West AP Jr, Bjorkman PJ. SARS-CoV-2 neutralizing antibody structures inform therapeutic strategies. Nature. 2020 Dec;588(7839):682-687. doi: 10.1038/s41586-020-2852-1. Epub 2020 Oct 12.

    PMID: 33045718BACKGROUND

  • Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/s41586-020-2456-9. Epub 2020 Jun 18.

    PMID: 32555388RESULT

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ogalvibart, crexavibart drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Marina Caskey
Organization
The Rockefeller University
mcaskey@rockefeller.edu
2123277396

Study Officials

  • Christian Gaebler, MD

    The Rockefeller University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

January 11, 2021

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

March 13, 2025

Results First Posted

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)