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.
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:
- 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.
- 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.
[Exclusion Criteria]
A 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 malignancy within past 5 years or any current malignancy
- Current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C
- 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):
- 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
- 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
- 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
- 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.
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.
- Conditions
- SARS-CoV-2 Infection
- 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 group | Role | What they receive |
|---|---|---|
| CT-P63 | Experimental | Single Ascending Dose Receives: Drug: CT-P63 |
| Placebo | Placebo comparator | Single Ascending Dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of single ascending dose of CT-P63:
- Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0
- Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0
- 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)
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
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
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
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
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
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Maximum observed serum concentration(Cmax)
Measured: Up to 90 Days
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
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Time to Cmax(Tmax)
Measured: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Terminal elimination half-life(t1/2)
Measured: Up to 90 Days
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
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
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Total body clearance(CL)
Measured: Up to 90 Days
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.
- First posted23 Aug 2021
- Study start11 Oct 2021
- Primary completion12 Nov 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Kiecana, Dr., Principal investigator, Biokinetica S.A.
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. 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-P63 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05017168
- Acronym / sponsor ID
- CT-P63 1.1
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P63 | Experimental | Drug: CT-P63Single Ascending Dose |
| Placebo | Placebo comparator | Drug: PlaceboSingle Ascending Dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-P63CT-P63 will be administered | Drug | CT-P63 |
| PlaceboPlacebo-matching CT-P63 | Drug | Placebo |
Primary outcome
To evaluate safety and tolerability of single ascending dose of CT-P63:
Time frame: Up to 14 Days
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
13 secondary outcomes
To evaluate immunogenicity of single ascending dose of CT-P63:
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Time frame: Up to 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
Monika Kiecana, Dr. principal investigator
Biokinetica S.A.
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-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.