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SARS-CoV-2 InfectionPhase 1NCT05017168

To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects

A Phase 1 study testing CT-P63 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in Poland.

Completed

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

Official record
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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-P63 in Healthy Subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
CT-P63
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 sitePoland
Study dates
11 Oct 2021to 25 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

[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 18 to 60 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 with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive).
  3. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.

[Exclusion Criteria]

A 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):
  2. 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
  3. 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
  4. History of malignancy within past 5 years or any current malignancy
  5. Current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C
  6. 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
  7. 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
  8. 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
  9. Subject had a history of or concurrent use of medications including any prior therapy of following(s):
  10. Any vaccination within 4 weeks prior to the study drug administration. For SARS-CoV-2 vaccine, subject who received any investigational or approved SARS-CoV-2 vaccine cannot be enrolled, regardless of the timing of administration
  11. 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
  12. 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
  13. 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.

Poland1 site
  • Biokinetica S.A

    Józefów, 05-410

Other trials in Poland

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-P63 in Healthy Subjects

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-P63 in Healthy Subjects.

Read the detailed description

CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 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-P63 will be evaluated in healthy subjects.

Being tested
CT-P63, 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-P63Drug

    CT-P63 will be administered

  • PlaceboDrug

    Placebo-matching CT-P63

Study groups in NCT05017168
Study groupRoleWhat they receive
CT-P63ExperimentalSingle Ascending Dose
Receives: Drug: CT-P63
PlaceboPlacebo comparatorSingle Ascending Dose
Receives: Drug: Placebo

What is being measured

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

  1. To evaluate safety and tolerability of single ascending dose of CT-P63:

    1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0
    2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0
    3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0

    Measured: Up to 14 Days

Secondary outcomes (13)
  1. To evaluate immunogenicity of single ascending dose of CT-P63:

    Incidence of ADA and NAbs to CT-P63 (positive or negative)

    Measured: Up to 90 Days

  2. To evaluate the Pharmacokinetic(PK) of CT-P63

    Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to infinity, calculated using the linear up and low down trapezoidal rule(AUC0-inf)

    Measured: Up to 90 Days

  3. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose)

    Measured: Up to 90 Days

  4. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Area under the serum concentration-time curve from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last)

    Measured: Up to 90 Days

  5. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose)

    Measured: Up to 90 Days

  6. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Maximum observed serum concentration(Cmax)

    Measured: Up to 90 Days

  7. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)

    Measured: Up to 90 Days

  8. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Time to Cmax(Tmax)

    Measured: Up to 90 Days

  9. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Terminal elimination half-life(t1/2)

    Measured: Up to 90 Days

  10. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext)

    Measured: Up to 90 Days

  11. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz)

    Measured: Up to 90 Days

  12. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Total body clearance(CL)

    Measured: Up to 90 Days

  13. To evaluate the Pharmacokinetic(PK) of CT-P63

    PK parameter: Volume of distribution at steady state (Vss)

    Measured: Up to 90 Days

Timeline

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

  1. First posted23 Aug 2021
  2. Study start11 Oct 2021
  3. Primary completion12 Nov 2021
  4. Study completion25 Jan 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05017168
Sponsor's protocol ID
CT-P63 1.1
Other IDs
2021-003530-37
Status last verified
Aug 2022
First submitted
29 Jul 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-P63 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in Poland.

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

Who may be eligible to take part?

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 11 Aug 2022. 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 Poland. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate safety and tolerability of single ascending dose of CT-P63: (time frame: Up to 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Aug 2022.

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