Postmenopausal OsteoporosisPhase 1NCT04940845
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
A Phase 1 study testing HS-20090-2 and Prolia in people with Postmenopausal Osteoporosis, run by Shanghai Hansoh Biomedical Co., Ltd at 1 site in China.
Trial summary
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- HS-20090-2 and Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to Jun 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
- Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
- Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;
- Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.
Who cannot join
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
- Serum calcium levels are outside the normal range of the laboratory.
- Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer).
- Prior use of medications within 12 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technoogy
Wuhan, Hubei
Dong liu, PhD, 13507183749 ext. +86, tjyxboffice@sinq.com
Xiuhua Ren, Master, 15902713190 ext. +86, 271052026@qq.com
About this study
Official title: A Randomized, Single-blinded and Parallel Study to Assess the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
Read the detailed description
This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- HS-20090-2, Prolia
- Keywords
- osteoporosis，postmenopausal
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20090-2Drug
Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
ProliaDrug
Subcutaneously injection of Prolia® (60mg/1mL) once on the first day
| Study group | Role | What they receive |
|---|---|---|
| HS-20090-2 | Experimental | Not described Receives: Drug: HS-20090-2 |
| Prolia® | Active comparator | Not described Receives: Drug: Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-infinity curve (AUC0-∞ )
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.
Measured: 155days
Cmax
maximum concentration
Measured: 155days
Secondary outcomes (3)
Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Measured: 155days
ADA
percentage of subjects positive for antidrug antibody
Measured: 155days
Nab
percentage of subjects positive for Nab
Measured: 155days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start26 Jul 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hansoh Biomedical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Liu, PhD, Principal investigator, Huazhong University of Science and TechnoogyXiuhua Ren, Master, Principal investigator, Huazhong University of Science and Technoogy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940845
- Sponsor's protocol ID
- HS-20090-2-101
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blinded and Parallel Study to Assess the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
- ClinicalTrials.gov ID
- NCT04940845
- Acronym / sponsor ID
- HS-20090-2-101
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- osteoporosis，postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Shanghai Hansoh Biomedical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Jun 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.
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
Detailed description
This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20090-2 | Experimental | Drug: HS-20090-2 |
| Prolia® | Active comparator | Drug: Prolia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
- Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
- Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;
- Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.
Key exclusion criteria (5 listed)
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
- Serum calcium levels are outside the normal range of the laboratory.
- Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer).
- Prior use of medications within 12 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics
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 |
|---|---|---|
| HS-20090-2Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day | Drug | HS-20090-2 |
| ProliaSubcutaneously injection of Prolia® (60mg/1mL) once on the first day | Drug | Prolia® |
Primary outcome
Area under the plasma concentration-infinity curve (AUC0-∞ )
Time frame: 155days
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.
Cmax
Time frame: 155days
maximum concentration
3 secondary outcomes
Adverse events(AE)
Time frame: 155days
ADA
Time frame: 155days
Nab
Time frame: 155days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- 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.
Dong Liu, PhD principal investigator
Huazhong University of Science and Technoogy
Xiuhua Ren, Master principal investigator
Huazhong University of Science and Technoogy
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 HS-20090-2 and Prolia in people with Postmenopausal Osteoporosis, run by Shanghai Hansoh Biomedical 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Liu, PhD (13507183749 ext. +86, tjyxboffice@sinq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-infinity curve (AUC0-∞ ) (time frame: 155days). 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?
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 25 Aug 2021.