HealthyPhase 1NCT03247673
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
A Phase 1 study testing CT-P16, EU-approved Avastin and US-licensed Avastin in people with Healthy, run by Celltrion at 3 sites in South Korea.
Trial summary
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CT-P16, EU-approved Avastin and US-licensed Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 7 Aug 2017to 17 Jan 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 19 and 55 years, both inclusive
- Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg
Who cannot join
- Subject is a female.
- Clinically significant allergic reactions, hypersensitivity
- A disease classed as significant by the Investigator
- Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury
- Any malignancy
- Undergone treatment with an investigational drug or participated in another clinical trial
- Plans to father a child or donates sperms
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Inje University Busan Paik Hospital
Busan
Inha University Hospital
Incheon
Seoul St.Mary's hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects
Read the detailed description
This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.
- Conditions
- Healthy
- Being tested
- CT-P16, EU-approved Avastin, US-licensed Avastin
- Keywords
- safety, Pharmacokinetics, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P16Drug
Also called bevacizumab
CT-P16 is a biosimilar product for Avastin
EU-approved AvastinDrug
Also called bevacizumab
EU-approved Avastin
US-licensed AvastinDrug
Also called bevacizumab
US-licensed Avastin
| Study group | Role | What they receive |
|---|---|---|
| CT-P16 | Experimental | CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects Receives: Drug: CT-P16 |
| EU-approved Avastin | Active comparator | EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects Receives: Drug: EU-approved Avastin |
| US-licensed Avastin | Active comparator | US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects Receives: Drug: US-licensed Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the concentration-time curve from time zero to infinity
Measured: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Cmax
Maximum Serum Concentration (Cmax)
Measured: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
AUC0-last
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Measured: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Secondary outcomes (2)
Additional Pharmacokinetics (Time to Cmax)
To assess the additional PK of study drugs (Time to Cmax)
Measured: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Number of Participants With Anti-Drug Antibody Positive
number of participants with anti-drug antibody positive at post-dose
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start7 Aug 2017
- Primary completion22 Dec 2017
- Study completion17 Jan 2018
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Young Lee, Study director, Celltrion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247673
- Sponsor's protocol ID
- CT-P16 1.1
- Status last verified
- Mar 2020
- First submitted
- 3 Aug 2017
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin(R) and US-Avastin(R) in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. BioDrugs. 2026 Aug 2. doi: 10.1007/s40259-026-00800-1. Online ahead of print.
PubMed 42542998Cho SH, Han S, Ghim JL, Nam MS, Yu S, Park T, Kim S, Bae J, Shin JG. A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males. BioDrugs. 2019 Apr;33(2):173-181. doi: 10.1007/s40259-019-00340-x.
PubMed 30850957
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03247673
- Acronym / sponsor ID
- CT-P16 1.1
- Conditions
- Healthy
- Keywords
- safety, Pharmacokinetics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 25 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects
Detailed description
This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-P16 | Experimental | Drug: CT-P16CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
| EU-approved Avastin | Active comparator | Drug: EU-approved AvastinEU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
| US-licensed Avastin | Active comparator | Drug: US-licensed AvastinUS-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between the ages of 19 and 55 years, both inclusive
- Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg
Key exclusion criteria (7 listed)
- Subject is a female.
- Clinically significant allergic reactions, hypersensitivity
- A disease classed as significant by the Investigator
- Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury
- Any malignancy
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-P16Also: bevacizumabCT-P16 is a biosimilar product for Avastin | Drug | CT-P16 |
| EU-approved AvastinAlso: bevacizumabEU-approved Avastin | Drug | EU-approved Avastin |
| US-licensed AvastinAlso: bevacizumabUS-licensed Avastin | Drug | US-licensed Avastin |
Primary outcome
AUC0-inf
Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Area under the concentration-time curve from time zero to infinity
Cmax
Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Maximum Serum Concentration (Cmax)
AUC0-last
Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
2 secondary outcomes
Additional Pharmacokinetics (Time to Cmax)
Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Number of Participants With Anti-Drug Antibody Positive
Time frame: up to 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42542998Kim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin(R) and US-Avastin(R) in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. BioDrugs. 2026 Aug 2. doi: 10.1007/s40259-026-00800-1. Online ahead of print.
- Derived from this study: PubMed 30850957Cho SH, Han S, Ghim JL, Nam MS, Yu S, Park T, Kim S, Bae J, Shin JG. A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males. BioDrugs. 2019 Apr;33(2):173-181. doi: 10.1007/s40259-019-00340-x.
- Celltrion, Inc. homepageLink provided by the sponsor.
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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.
Sung Young Lee study director
Celltrion
3 sites 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-P16, EU-approved Avastin and US-licensed Avastin in people with Healthy, run by Celltrion at 3 sites 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 2 inclusion and 7 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 25 Jul 2019). 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?
AUC0-inf (time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI). The study lists 3 primary outcomes in all. 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 NCT03247673, 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 26 Mar 2020.