Postmenopausal OsteoporosisPhase 1NCT03925051
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
A Phase 1 study testing Prolia® and CMAB807 in people with Postmenopausal Osteoporosis, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Prolia® and CMAB807
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 18 Jun 2020
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
- 18 years ≤ age ≤65 years;
- Physical examination, vital signs, clinical laboratory examination and various examinations are normal or abnormal without clinical significance;
- Agree to take effective contraceptive measures throughout the study period (including not limited to: physical contraception, hormonal drugs of pregnancy, surgery, abstinence, etc.,) until at least 10 months after the last study is administered;
- Body weight ≥50 kg, 19kg/m2≤BMI≤26kg/m2;
- Serum calcium level between 2.15~2.55mmol/L（including the boundary value）;
- Normal or clinically acceptable electrocardiogram (12-lead ECG), QTcB<450msec.
Who cannot join
- Drink 14 units of alcohol per week within 3 months prior to administration, or take any alcohol substance within 48 hours before subcutaneous injection;
- Substance abuse within 5 years before subcutaneous injection;
- Smoke more than 5 cigarettes per day or the same amount of tobacco within 3 months before subcutaneous injection;
- Allergic constitution;
- Drink excessive amounts of tea, coffee or caffeinated beverages within 30 days before subcutaneous injection;
- Use any prescription, over-the-counter, vitamin or herbal medicine within 30 days before subcutaneous injection;
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- Bone surgery was performed within 30 days before administration;
- History of osteomyelitis or osteonecrosis of the jaw;
- Inflammation or abnormalities in or around the site of administration;
- Needle or blood sickness;
- Dental disease or jaw disease requiring oral surgery, dental surgery; or plan to have dental surgery during the study;
- Received the study drug(including Xgeva and Prolia), or participated in a clinical trial within 3 months prior to administration；
- Received living viraL vaccine within 3 months prior to administration;
- Blood donation or blood loss >400ml within 3 months prior to administration;
- Hepatitis B surface antigen was positive, and/or hepatitis C antibody was positive;
- The HIV antibody test was not negative;
- Syphilitic test was positive;
- Drug was detected in the urine;
- Hyperparathyroidism, hypothyroidism, rheumatoid arthritis, Ankylosing Spondylitis, osteomalacia, Paget's disease, or fracture within 6 months;
- History of severe lumbar disc herniation;
- Insanity or legal problem are exist;
- Plan to engage in strenuous physical labor or exercise during the study;
- Other conditions that made it difficult to participate the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects.
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.
Read the detailed description
This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®.
Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Prolia®, CMAB807
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolia®Drug
Also called Denosumab Injection
mAb targeting RANKL. human monoclonal antibody targeting RANKL.
CMAB807Drug
Also called Denosumab Injection
human monoclonal antibody targeting RANKL.
| Study group | Role | What they receive |
|---|---|---|
| CMAB807 | Experimental | 60mg by subcutaneous injection once on the first day. Receives: Drug: CMAB807 |
| Prolia® | Active comparator | 60mg by subcutaneous injection once on the first day. Receives: Drug: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area Under Curve(AUC)0-t
Measured: 0~126 day
Cmax
Maximum Concentration
Measured: 0~126 day
Secondary outcomes (3)
Incidence of Adverse Event
measured by common terminology criteria for adverse events grading
Measured: 0~126 day
Antidrug Antibody
Percentage of Subjects Positive for Antidrug Antibody
Measured: 0~126 day
Serum type 1 C-telopeptide(CTX1)
explore the pharmacodynamic profile by detect the serum concentration of CTX1
Measured: 0~126 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Jul 2019
- Primary completion21 Mar 2020
- Study completion18 Jun 2020
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 Postmenopausal OsteoporosisStudies 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
- Parallel groups
- Model description
- Randomized, Double-masked, Parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xuening li, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925051
- Sponsor's protocol ID
- CMAB807-I-001
- Status last verified
- Oct 2020
- First submitted
- 18 Apr 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, Chen W, Yuan F, Guo Q, Zhang X, Wang C, Li X. Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects. Front Pharmacol. 2022 Jan 24;13:821944. doi: 10.3389/fphar.2022.821944. eCollection 2022.
PubMed 35140619
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects.
- ClinicalTrials.gov ID
- NCT03925051
- Acronym / sponsor ID
- CMAB807-I-001
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 23 Apr 2019 (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.
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.
Detailed description
This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®.
Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-masked, Parallel-group
| Arm | Type | Receives |
|---|---|---|
| CMAB807 | Experimental | Drug: CMAB80760mg by subcutaneous injection once on the first day. |
| Prolia® | Active comparator | Drug: Prolia®60mg by subcutaneous injection once on the first day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
- 18 years ≤ age ≤65 years;
- Physical examination, vital signs, clinical laboratory examination and various examinations are normal or abnormal without clinical significance;
- Agree to take effective contraceptive measures throughout the study period (including not limited to: physical contraception, hormonal drugs of pregnancy, surgery, abstinence, etc.,) until at least 10 months after the last study is administered;
- Body weight ≥50 kg, 19kg/m2≤BMI≤26kg/m2;
Key exclusion criteria (23 listed)
- Drink 14 units of alcohol per week within 3 months prior to administration, or take any alcohol substance within 48 hours before subcutaneous injection;
- Substance abuse within 5 years before subcutaneous injection;
- Smoke more than 5 cigarettes per day or the same amount of tobacco within 3 months before subcutaneous injection;
- Allergic constitution;
- Drink excessive amounts of tea, coffee or caffeinated beverages within 30 days before subcutaneous injection;
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 |
|---|---|---|
| Prolia®Also: Denosumab InjectionmAb targeting RANKL. human monoclonal antibody targeting RANKL. | Drug | Prolia® |
| CMAB807Also: Denosumab Injectionhuman monoclonal antibody targeting RANKL. | Drug | CMAB807 |
Primary outcome
AUC0-t
Time frame: 0~126 day
Area Under Curve(AUC)0-t
Cmax
Time frame: 0~126 day
Maximum Concentration
3 secondary outcomes
Incidence of Adverse Event
Time frame: 0~126 day
Antidrug Antibody
Time frame: 0~126 day
Serum type 1 C-telopeptide(CTX1)
Time frame: 0~126 day
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 Oct 2020.
- Derived from this study: PubMed 35140619Chen H, Chen W, Yuan F, Guo Q, Zhang X, Wang C, Li X. Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects. Front Pharmacol. 2022 Jan 24;13:821944. doi: 10.3389/fphar.2022.821944. eCollection 2022.
- 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.
xuening li, PhD study chair
Fudan University
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 Prolia® and CMAB807 in people with Postmenopausal Osteoporosis, run by Shanghai Biomabs Pharmaceutical Co., Ltd. at 1 site in China.
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 7 inclusion and 23 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 Oct 2020. 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 China. 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?
AUC0-t (time frame: 0~126 day). The study lists 2 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 NCT03925051, 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 Oct 2020.