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CompletedNCT04525079Updated Nov 16, 2021Results posted

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects

A Phase 1 interventional study of CT-P59 and Placebo in SARS-CoV-2 Infection, sponsored by Celltrion. Completed at 1 site in South Korea. Open to participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Celltrion · Phase 1, Interventional, and Screening

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects.

Read the detailed description

CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P59 will be evaluated in healthy subjects.

02

Conditions studied

  • SARS-CoV-2 Infection

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Celltrion is the lead sponsor of 77 studies on the registry; 2 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 14 (74%) have results posted.

Browse Celltrion studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Each subject must meet all of the following criteria to be randomized in this study:

  1. Subject is a healthy male or female subject, aged between 19 to 55 years (both inclusive). Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration.
  2. Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits.
  3. Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
  4. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
  5. Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Exclusion criteria

Exclusion Criteria:

Subject meeting any of the following criteria will be excluded from the study:

  1. Subject has a medical history or current presence of disease including one or more of the following(s):

    1. History of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the Investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug
    2. History of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the Investigator
    3. History of or any concomitant active malignancy
    4. History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C
    5. History of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required IV antibiotics) within 6 months before the study drug administration
    6. History of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the Investigator or requires hospitalization
    7. History of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period

  2. Subject had a history of or concurrent use of medications including any prior therapy of following(s):

    1. Prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration
    2. Any vaccination within 4 weeks prior to the study drug administration
    3. Treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics
    4. Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration
05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Cohort 1 will receive a dose of CT-P59 or matching placebo

    Drug: CT-P59 · Drug: Placebo

  • Experimental
    Cohort 2

    Cohort 2 will receive a dose of CT-P59 or matching placebo

    Drug: CT-P59 · Drug: Placebo

  • Experimental
    Cohort 3

    Cohort 3 will receive a dose of CT-P59 or matching placebo

    Drug: CT-P59 · Drug: Placebo

  • Experimental
    Cohort 4

    Cohort 4 will receive a dose of CT-P59 or matching placebo

    Drug: CT-P59 · Drug: Placebo

Interventions

  • DrugCT-P59

    CT-P59 will be administered

  • DrugPlacebo

    Placebo-matching CT-P59

06

What researchers measure

Primary outcomes

  1. Preliminary Safety and Tolerability of CT-P59

    A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.

    Time frame: Up to Day 14 after the subject administered with the study drug (Day 1)

Secondary outcomes

  1. Additional Safety of CT-P59 Including Immunogenicity

    A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.

    Time frame: Up to 90 Days

  2. Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last

    Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59.

    Time frame: Up to 90 Days

  3. Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose

    Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)

    Time frame: Up to Day 90

  4. Pharmacokinetic (PK) Parameter: Cmax

    Data contains Maximum observed serum concentration(Cmax) of CT-P59

    Time frame: Up to Day 90

  5. Pharmacokinetic (PK) Parameter: Cmax/Dose

    Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59

    Time frame: Up to Day 90

  6. Pharmacokinetic (PK) Parameter: Tmax

    Data indicates Time to Cmax(Tmax) of CT-P59

    Time frame: Up to 90 Days

  7. Pharmacokinetic (PK) Parameter: t1/2

    Data contains Terminal half-life (t1/2) of CT-P59

    Time frame: Up to Day 90

  8. Pharmacokinetic (PK) Parameter: %AUCext

    Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59

    Time frame: Up to Day 90

  9. Pharmacokinetic (PK) Parameter: λz

    Data contains Terminal elimination rate constant (λz) of CT-P59

    Time frame: Up to Day 90

  10. Pharmacokinetic (PK) Parameter: CL

    Data contains Total body clearance (CL) of CT-P59

    Time frame: Up to Day 90

  11. Pharmacokinetic (PK) Parameter: Vz

    Data contains Volume of distribution during the elimination phase (Vz) of CT-P59

    Time frame: Up to Day 90

07

Results

Posted Nov 16, 2021

Participant flow

Participant flow — Overall Study
MilestoneCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlacebo
Started66668
Completed66668
Not completed00000

Outcome measures

PrimaryPreliminary Safety and Tolerability of CT-P59

A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.

Time frame:
Up to Day 14 after the subject administered with the study drug (Day 1)
Reported as:
Count of participants · Participants
Preliminary Safety and Tolerability of CT-P59
ParticipantsCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlacebo
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)02101
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs)00000
Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI)00001
SecondaryAdditional Safety of CT-P59 Including Immunogenicity

A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.

Time frame:
Up to 90 Days
Reported as:
Count of participants · Participants
Additional Safety of CT-P59 Including Immunogenicity
ParticipantsCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlacebo
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)04301
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs)01000
Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI)00001
Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P5900000
SecondaryPharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last

Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59.

Time frame:
Up to 90 Days
Reported as:
Mean · hr*ng/mL
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
hr*ng/mLCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P5952469185.0 ± 20377788.5488353384.1 ± 17775504.91167086786.9 ± 21899708.77335692549.3 ± 58444099.42
Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last)49593090.2 ± 15304853.5486246911.1 ± 15738302.53164581603.9 ± 21359705.90321167775.4 ± 47167390.53
SecondaryPharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose

Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)

Time frame:
Up to Day 90
Reported as:
Mean · hr*ng/mL/mg
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
hr*ng/mL/mgCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose)68774.1 ± 22010.2570620.6 ± 20122.5254763.5 ± 6031.1658981.8 ± 7971.33
Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose)65200.8 ± 15941.7768847.6 ± 18138.8653932.1 ± 5721.2156474.7 ± 6274.98
SecondaryPharmacokinetic (PK) Parameter: Cmax

Data contains Maximum observed serum concentration(Cmax) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · ng/mL
Pharmacokinetic (PK) Parameter: Cmax
ng/mLCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: Cmax233166.7 ± 37796.38406333.3 ± 43647.071020000.0 ± 240084.151941666.7 ± 267538.16
SecondaryPharmacokinetic (PK) Parameter: Cmax/Dose

Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · ng/mL/mg
Pharmacokinetic (PK) Parameter: Cmax/Dose
ng/mL/mgCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: Cmax/Dose307.1 ± 27.11321.5 ± 45.42337.0 ± 91.60342.0 ± 44.74
SecondaryPharmacokinetic (PK) Parameter: Tmax

Data indicates Time to Cmax(Tmax) of CT-P59

Time frame:
Up to 90 Days
Reported as:
Median · hr
Pharmacokinetic (PK) Parameter: Tmax
hrCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: Tmax2.080 (1.57 to 2.6)1.575 (1.48 to 5.48)2.070 (1.5 to 2.67)2.430 (1.53 to 13.63)
SecondaryPharmacokinetic (PK) Parameter: t1/2

Data contains Terminal half-life (t1/2) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · hr
Pharmacokinetic (PK) Parameter: t1/2
hrCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: t1/2473.3 ± 181.26426.4 ± 84.52398.6 ± 36.30526.8 ± 106.62
SecondaryPharmacokinetic (PK) Parameter: %AUCext

Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · Percentage of AUC0-inf
Pharmacokinetic (PK) Parameter: %AUCext
Percentage of AUC0-infCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: %AUCext3.834 ± 5.20352.120 ± 1.67241.478 ± 0.597704.005 ± 2.3526
SecondaryPharmacokinetic (PK) Parameter: λz

Data contains Terminal elimination rate constant (λz) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · 1/hr
Pharmacokinetic (PK) Parameter: λz
1/hrCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: λz0.001586 ± 0.000383160.001673 ± 0.000289130.001751 ± 0.000161190.001356 ± 0.00024242
SecondaryPharmacokinetic (PK) Parameter: CL

Data contains Total body clearance (CL) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · mL/hr
Pharmacokinetic (PK) Parameter: CL
mL/hrCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: CL15.46 ± 3.504514.98 ± 3.616518.46 ± 2.128517.20 ± 2.2033
SecondaryPharmacokinetic (PK) Parameter: Vz

Data contains Volume of distribution during the elimination phase (Vz) of CT-P59

Time frame:
Up to Day 90
Reported as:
Mean · mL
Pharmacokinetic (PK) Parameter: Vz
mLCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kg
Pharmacokinetic (PK) Parameter: Vz9848.9 ± 950.018880.3 ± 907.1010532.2 ± 580.9612805.5 ± 937.08

Adverse events

Collected over Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CT-P59 10 mg/kg0/6 (0%)0/6 (0%)0/6 (0%)
CT-P59 20 mg/kg0/6 (0%)1/6 (16.7%)4/6 (66.7%)
CT-P59 40 mg/kg0/6 (0%)0/6 (0%)3/6 (50%)
CT-P59 80 mg/kg0/6 (0%)0/6 (0%)0/6 (0%)
Placebo0/8 (0%)0/8 (0%)1/8 (12.5%)
Most frequent serious events
Most frequent serious events
EventCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlacebo
Limb injuryInjury, poisoning and procedural complications0/61/60/60/60/8
Most frequent other events
Most frequent other events
EventCT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlacebo
PyrexiaGeneral disorders0/60/61/60/60/8
Blood creatine phosphokinase increasedInvestigations0/61/61/60/60/8
C-reactive protein increasedInvestigations0/61/60/60/60/8
Gamma-glutamyltransferase increasedInvestigations0/60/61/60/60/8
White blood cells urine positiveInvestigations0/60/61/60/60/8
HeadacheNervous system disorders0/61/60/60/60/8
UrticariaSkin and subcutaneous tissue disorders0/61/60/60/60/8
Infusion related reactionInjury, poisoning and procedural complications0/60/60/60/61/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
<=18 years000000
Between 18 and 65 years6666832
>=65 years000000
Age, Continuous
Age, Continuous(years)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
Median33.5 (21 to 43)23.5 (22 to 38)28.5 (20 to 34)21.5 (19 to 28)25 (19 to 43)24 (19 to 43)
Sex: Female, Male
Sex: Female, Male(Participants)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
Female000000
Male6666832
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
Hispanic or Latino000000
Not Hispanic or Latino6666832
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
American Indian or Alaska Native000000
Asian6666832
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White000000
More than one race000000
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)CT-P59 10 mg/kgCT-P59 20 mg/kgCT-P59 40 mg/kgCT-P59 80 mg/kgPlaceboTotal
South Korea6666832
08

Study locations

1 site
  • Chungnam National University Hospital
    Daejeon, South Korea
09

References and documents

Publications

  • Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23. PubMed 34551869 ↗
  • 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. PubMed 34473343 ↗

Study documents

  • Study protocol · Jul 3, 2020
  • Statistical analysis plan · Nov 30, 2020

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Aug 2020, 0 months.

Results were first posted in Nov 2021, 1 year 3 months after primary completion.

Of 176 industry-sponsored phase 1 interventional studies under COVID-19, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 0 months is below that.

Counting every sponsor, half of 314 studies reached it within 8 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2020
First posted
Aug 25, 2020
StartActual
Jul 18, 2020
Primary completionActual
Aug 7, 2020
CompletionActual
Nov 5, 2020
Results first posted
Nov 16, 2021
Last update
Nov 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04525079
Lead sponsor
Celltrion
Responsible party
Sponsor
First posted
Aug 25, 2020
Start date
Jul 18, 2020
Primary completion
Aug 7, 2020
Completion
Nov 5, 2020
Results posted
Nov 16, 2021
Last update
Nov 16, 2021

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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