Healthy SubjectPhase 1NCT06037395
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
A Phase 1 study testing CT-P41 and US-licensed Prolia in people with Healthy Subject, run by Celltrion at 2 sites in South Korea.
Trial summary
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 28 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- CT-P41 and US-licensed Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Oct 2021to 20 Oct 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 28 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, between the ages of 28 and 55 years, both inclusive
- Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)
Who cannot join
- Subject was a female.
- Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).
- Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.
- Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.
- Subjects with known risk factors for hypocalcaemia
- Subjects with known intolerance to calcium or vitamin D supplements
Show all 9Show fewer
- Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis
- Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.
- Subjects have or had any therapy that might significantly affect bone metabolism
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chungnam National University Hospital
Daejeon, Jung-gu, 35015
CHA Bundang Medical Center
Seongnam, Bundang-gu, 13520
About this study
Official title: A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Read the detailed description
This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.
- Conditions
- Healthy Subject
- Being tested
- CT-P41, US-licensed Prolia
- Keywords
- CT-P41
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P41Biological
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed ProliaBiological
a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| CT-P41 | Experimental | a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: CT-P41 |
| US-licensed Prolia | Active comparator | a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: US-licensed Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: up to Day 253
AUClast
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Measured: up to Day 253
Cmax
maximum serum concentration (Cmax)
Measured: up to Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start6 Oct 2021
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, Parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037395
- Sponsor's protocol ID
- CT-P41 1.2
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim A, Hong JH, Shin W, Yoo H, Jung JG, Reginster JY, Kim S, Bae Y, Suh J, Kim S, Lee E, Silverman S. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT-P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663. doi: 10.1080/14712598.2024.2316846. Epub 2024 Feb 22.
PubMed 38349618
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06037395
- Acronym / sponsor ID
- CT-P41 1.2
- Conditions
- Healthy Subject
- Keywords
- CT-P41
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 14 Sep 2023 (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.
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Detailed description
This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, Parallel group
| Arm | Type | Receives |
|---|---|---|
| CT-P41 | Experimental | Biological: CT-P41a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) |
| US-licensed Prolia | Active comparator | Biological: US-licensed Proliaa single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subject, between the ages of 28 and 55 years, both inclusive
- Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)
Key exclusion criteria (9 listed)
- Subject was a female.
- Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).
- Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.
- Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.
- Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.
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-P41a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological | CT-P41 |
| US-licensed Proliaa single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological | US-licensed Prolia |
Primary outcome
AUCinf
Time frame: up to Day 253
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
AUClast
Time frame: up to Day 253
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Cmax
Time frame: up to Day 253
maximum serum concentration (Cmax)
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 14 Sep 2023.
- Derived from this study: PubMed 38349618Kim A, Hong JH, Shin W, Yoo H, Jung JG, Reginster JY, Kim S, Bae Y, Suh J, Kim S, Lee E, Silverman S. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT-P41 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jul;24(7):655-663. doi: 10.1080/14712598.2024.2316846. Epub 2024 Feb 22.
- Individual participant dataSharing planned: No
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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.
2 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-P41 and US-licensed Prolia in people with Healthy Subject, run by Celltrion at 2 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 3 inclusion and 9 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
AUCinf (time frame: up to Day 253). 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 NCT06037395, which also lists 1 linked publication.
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 14 Sep 2023.