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NCT04700163: RU

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

Completed Phase 1 Results posted Last updated 13 March 2025
What this trial tests

Phase 1 trial testing C144-LS and C-135-LS in Covid19 in 23 participants. Completed in 2 February 2022.

Timeline
11 January 2021
Primary endpoint
2 February 2022
2 February 2022

Quick facts

Lead sponsorRockefeller University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment23
Start date11 January 2021
Primary completion2 February 2022
Estimated completion2 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rockefeller University

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Grade 2 and Higher Adverse Events 4 Weeks After Administration. Primary · 4 weeks

The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).

GroupValue95% CI
S1 - Low Dose0
S2 - Mid Dose0
V1 - Low Dose0
V2 - Mid Dose0
V3 - High Dose0
S3 - Open Label0
Grade 3 and Higher Adverse Events 4 Weeks After Administration. Primary · 4 weeks

The number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).

GroupValue95% CI
S1 - Low Dose0
S2 - Mid Dose0
V1 - Low Dose0
V2 - Mid Dose0
V3 - High Dose0
S3 - Open Label0
Related Serious Adverse Events (SAEs) Throughout the Study Period Primary · 48 weeks

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

GroupValue95% CI
S1 - Low Dose0
S2 - Mid Dose0
V1 - Low Dose0
V2 - Mid Dose0
V3 - High Dose0
S3 - Open Label0
Elimination Half-life (t1/2) of C135-LS and C144-LS Primary · 48 weeks

Half-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers

C135-LS Half-life
GroupValue95% CI
S1 - Low Dose79.85± 10.84
S2 - Mid Dose89.55± 17.06
V1 - Low Dose90.79± 15.11
V2 - Mid Dose91.91± 12.57
V3 - High Dose96.24± 13.56
S3 - Open Label89.55± 17.06
C144-LS Half-life
GroupValue95% CI
S1 - Low Dose80.96± 14.58
S2 - Mid Dose107.3± 29.21
V1 - Low Dose96.37± 11.48
V2 - Mid Dose114.4± 3.444
V3 - High Dose103.5± 14.10
S3 - Open Label107.3± 29.2
Clearance Rate of C135-LS and C144-LS Primary · 48 weeks

Clearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers

C135-LS Clearance
GroupValue95% CI
S1 - Low Dose75.34± 33.54
S2 - Mid Dose70.58± 22.81
V1 - Low Dose53.13± 19.61
V2 - Mid Dose70.88± 13.89
V3 - High Dose62.75± 19.56
S3 - Open Label70.58± 22.81
C144-LS Clearance
GroupValue95% CI
S1 - Low Dose61.54± 7.105
S2 - Mid Dose61.43± 16.70
V1 - Low Dose35.34± 26.85
V2 - Mid Dose50.96± 7.965
V3 - High Dose44.86± 6.584
S3 - Open Label61.43± 16.70
Area Under the Curve of C135-LS and C144-LS Primary · 48 weeks

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

C135-LS AUC
GroupValue95% CI
S1 - Low Dose1327± 33.54
S2 - Mid Dose2833± 22.81
V1 - Low Dose1873± 6.6
V2 - Mid Dose6213± 27.92
V3 - High Dose19626± 6.464
S3 - Open Label2833± 22.81
C144-LS AUC
GroupValue95% CI
S1 - Low Dose1625± 35.03
S2 - Mid Dose3256± 16.79
V1 - Low Dose2816± 13.42
V2 - Mid Dose8641± 31.4
V3 - High Dose27452± 3.205
S3 - Open Label3256± 16.79
Investigational Product (IP)-Related Adverse Events During Study Follow up. Secondary · 48 weeks

The number of participants with treatment-related adverse events

GroupValue95% CI
S1 - Low Dose0
S2 - Mid Dose1
V1 - Low Dose0
V2 - Mid Dose0
V3 - High Dose2
S3 - Open Label0
Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups. Secondary · 48 weeks

Proportion of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response

C135-LS ADA
GroupValue95% CI
S1 - Low Dose1
S2 - Mid Dose2
V1 - Low Dose0
V2 - Mid Dose1
V3 - High Dose0
S3 - Open Label0
C144-LS ADA
GroupValue95% CI
S1 - Low Dose1
S2 - Mid Dose1
V1 - Low Dose0
V2 - Mid Dose0
V3 - High Dose0
S3 - Open Label0

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

S1 - Low Dose
Serious: 0/3 (0%)
Deaths: 0/3
S2 - Mid Dose
Serious: 0/3 (0%)
Deaths: 0/3
V1 - Low Dose
Serious: 0/3 (0%)
Deaths: 0/3
V2 - Mid Dose
Serious: 0/3 (0%)
Deaths: 0/3
V3 - High Dose
Serious: 0/3 (0%)
Deaths: 0/3
S3 - Open Label
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (16 terms — click to expand)

ReactionSystemS1 - Low DoseS2 - Mid DoseV1 - Low DoseV2 - Mid DoseV3 - High DoseS3 - Open Label
Injection Site PainSkin and subcutaneous tissue disorders——————
SARS-CoV-2 Antibody PositiveInfections and infestations——————
TendernessSkin and subcutaneous tissue disorders——————
ErythemaSkin and subcutaneous tissue disorders——————
PruritusSkin and subcutaneous tissue disorders——————
Peripheral edemaSkin and subcutaneous tissue disorders——————
EcchymosisSkin and subcutaneous tissue disorders——————
COVID-19Infections and infestations——————
Upper respiratory tract infectionInfections and infestations——————
Increased blood glucoseEndocrine disorders——————
ArthralgiaMusculoskeletal and connective tissue disorders——————
Back painMusculoskeletal and connective tissue disorders——————
DizzinessNervous system disorders——————
ParesthesiaNervous system disorders——————
Abnormal uterine bleedingReproductive system and breast disorders——————
TachypneaRespiratory, thoracic and mediastinal disorders——————

Data from ClinicalTrials.gov NCT04700163 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants.
    Wang Z, Schmidt F, Weisblum Y, Muecksch F, et al · · 2021 · cited 1264× · PMID 33567448 · DOI 10.1038/s41586-021-03324-6
  2. Tackling COVID-19 with neutralizing monoclonal antibodies.
    Corti D, Purcell LA, Snell G, Veesler D. · · 2021 · cited 300× · PMID 34087172 · DOI 10.1016/j.cell.2021.05.005
  3. Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection.
    Hwang YC, Lu RM, Su SC, Chiang PY, et al · · 2022 · cited 170× · PMID 34983527 · DOI 10.1186/s12929-021-00784-w
  4. Antibody feedback regulates immune memory after SARS-CoV-2 mRNA vaccination.
    Schaefer-Babajew D, Wang Z, Muecksch F, Cho A, et al · · 2023 · cited 157× · PMID 36473496 · DOI 10.1038/s41586-022-05609-w
  5. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
    Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2
  6. Prevention and therapy of SARS-CoV-2 and the B.1.351 variant in mice.
    Martinez DR, Schäfer A, Leist SR, Li D, et al · · 2021 · cited 46× · PMID 34289384 · DOI 10.1016/j.celrep.2021.109450
  7. Therapeutics for COVID-19 and post COVID-19 complications: An update.
    Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
  8. Recent Progress in the Discovery and Development of Monoclonal Antibodies against Viral Infections.
    Mokhtary P, Pourhashem Z, Mehrizi AA, Sala C, et al · · 2022 · cited 26× · PMID 36009408 · DOI 10.3390/biomedicines10081861

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Other recruiting trials for Covid19

Currently open trials in the same condition.

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