SARS-CoV-2 InfectionPhase 1NCT04525079

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

A Phase 1 study testing CT-P59 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 19 to 55 years
Conditions the study is for: SARS-CoV-2 Infection
What is being tested?: CT-P59
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteSouth Korea
Study dates: 18 Jul 2020to 5 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Each subject must meet all of the following criteria to be randomized in this study:
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.
Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits.
Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Who cannot join

Subject meeting any of the following criteria will be excluded from the study:
Subject has a medical history or current presence of disease including one or more of the following(s):
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
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
History of or any concomitant active malignancy
History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C

Show all 14Show fewer

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
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
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
Subject had a history of or concurrent use of medications including any prior therapy of following(s):
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
Any vaccination within 4 weeks prior to the study drug administration
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
Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chungnam National University Hospital
Daejeon

Other trials in South Korea

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the 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.

Conditions: SARS-CoV-2 Infection
Being tested: CT-P59, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P59Drug
CT-P59 will be administered
PlaceboDrug
Placebo-matching CT-P59

Study groups in NCT04525079
Study group	Role	What they receive
Cohort 1	Experimental	Cohort 1 will receive a dose of CT-P59 or matching placebo Receives: Drug: CT-P59; Drug: Placebo
Cohort 2	Experimental	Cohort 2 will receive a dose of CT-P59 or matching placebo Receives: Drug: CT-P59; Drug: Placebo
Cohort 3	Experimental	Cohort 3 will receive a dose of CT-P59 or matching placebo Receives: Drug: CT-P59; Drug: Placebo
Cohort 4	Experimental	Cohort 4 will receive a dose of CT-P59 or matching placebo Receives: Drug: CT-P59; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 14 after the subject administered with the study drug (Day 1)

Secondary outcomes (11)

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.
Measured: Up to 90 Days
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.
Measured: Up to 90 Days
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)
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax
Data contains Maximum observed serum concentration(Cmax) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax/Dose
Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: Tmax
Data indicates Time to Cmax(Tmax) of CT-P59
Measured: Up to 90 Days
Pharmacokinetic (PK) Parameter: t1/2
Data contains Terminal half-life (t1/2) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: %AUCext
Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: λz
Data contains Terminal elimination rate constant (λz) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: CL
Data contains Total body clearance (CL) of CT-P59
Measured: Up to Day 90
Pharmacokinetic (PK) Parameter: Vz
Data contains Volume of distribution during the elimination phase (Vz) of CT-P59
Measured: Up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 20205 Nov 2020

First posted25 Aug 2020
Study start18 Jul 2020
Primary completion7 Aug 2020
Study completion5 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Screening
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04525079
Sponsor's protocol ID: CT-P59 1.1
Other IDs: 2020-003065-19
Status last verified: Sep 2021
First submitted: 30 Jul 2020
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
ClinicalTrials.gov ID: NCT04525079
Acronym / sponsor ID: CT-P59 1.1
Conditions: SARS-CoV-2 Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 18 Jul 2020 (actual)
Primary completion: 7 Aug 2020 (actual)
Study completion: 5 Nov 2020 (actual)
First posted: 25 Aug 2020 (actual)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cohort 1	Experimental	Drug: CT-P59, Drug: PlaceboCohort 1 will receive a dose of CT-P59 or matching placebo
Cohort 2	Experimental	Drug: CT-P59, Drug: PlaceboCohort 2 will receive a dose of CT-P59 or matching placebo
Cohort 3	Experimental	Drug: CT-P59, Drug: PlaceboCohort 3 will receive a dose of CT-P59 or matching placebo
Cohort 4	Experimental	Drug: CT-P59, Drug: PlaceboCohort 4 will receive a dose of CT-P59 or matching placebo

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.
Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits.
Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.

Key exclusion criteria (14 listed)

Subject has a medical history or current presence of disease including one or more of the following(s):
Subject had a history of or concurrent use of medications including any prior therapy of following(s):

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P59CT-P59 will be administered	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4
PlaceboPlacebo-matching CT-P59	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Preliminary Safety and Tolerability of CT-P59
Time frame: Up to Day 14 after the subject administered with the study drug (Day 1)
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.

11 secondary outcomes

Additional Safety of CT-P59 Including Immunogenicity
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax/Dose
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Tmax
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameter: t1/2
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: %AUCext
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: λz
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: CL
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Vz
Time frame: Up to Day 90

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P59 10 mg/kg	6	6
CT-P59 20 mg/kg	6	6
CT-P59 40 mg/kg	6	6
CT-P59 80 mg/kg	6	6
Placebo	8	8

Primary outcome: Preliminary Safety and Tolerability of CT-P59

Time frame: Up to Day 14 after the subject administered with the study drug (Day 1). Count of participants. Unit: Participants

Measure	CT-P59 20 mg/kg n = 6	CT-P59 40 mg/kg n = 6	Placebo n = 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	2	1	1
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs)	0	0	0
Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI)	0	0	1

Population analysed: Safety set: All subjects who receive a full or partial dose of the study drugs

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P59 10 mg/kg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
CT-P59 20 mg/kg	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
CT-P59 40 mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
CT-P59 80 mg/kg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Placebo	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34551869Kim 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.
Derived from this study: PubMed 34473343Kreuzberger 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-P59 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preliminary Safety and Tolerability of CT-P59 (time frame: Up to Day 14 after the subject administered with the study drug (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525079, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.