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OsteoporosisPhase 1NCT07384104

Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects

A Phase 1 study testing SAL0123 and Romosozumab in people with Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Primary objective of this study is to evaluate the similarity in pharmacokinetic characteristics between SAL023 Injection and Italy-manufactured Evenity. Secondary objective is to assess the similarity in safety, pharmacodynamic and immunogenicity profiles of SAL023 Injection and Italy-manufactured Evenity. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Osteoporosis
What is being tested?
SAL0123 and Romosozumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteChina
Study dates
19 Oct 2025to 5 Feb 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have a full understanding of the study, voluntarily sign the written informed consent form (ICF), and be able to comply with the requirements and restrictions specified in the ICF.
  • Healthy Chinese male or female subjects.
  • Aged 18 to 45 years old (inclusive of both endpoints).
  • Body weight ≥ 50 kg and body mass index (BMI) ranging from 19.0 to 25.0 kg/m² (inclusive of both endpoints; BMI = weight ÷ height²).
  • Results of all examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, myocardial enzymes, thyroid function, serum virology, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal ultrasound, etc.) are normal or have minor abnormalities that are judged as not clinically insignificant by the investigator.
  • The subject or their partner has no pregnancy plans during the study period and within 3 months after the last administration of the study drug, and voluntarily adopts effective contraceptive measures (contraceptives are prohibited during the study period) to avoid pregnancy of themselves or their partner; in addition, the subject will not donate sperm or ova (egg cells, oocytes) for reproductive or assisted reproductive purposes.

Who cannot join

  • A history of clinically significant acute drug or food allergic reactions within 2 weeks prior to screening; or allergic diathesis (e.g., allergy to two or more drugs, foods or pollen); or a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.); or a possible or definite allergy to the study drug (including similar drugs or the control drug) and any of its excipients, hypersensitivity reactions, or clinically significant notable reactions as judged by the investigator.
  • Positive result for any of the following tests: hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.
  • Bone mineral density T-score ≤ -2.5 at any of the following sites: lumbar vertebrae L1-L4 (total), total hip joint, or femoral neck during the screening period.
  • Serum calcium, creatinine, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), or parathyroid hormone levels outside the normal reference range.
  • A history of any of the following diseases: history of hip fracture or fracture at any other site within 6 months prior to the first administration; history of myocardial infarction; history of cerebral infarction or ischemic stroke.
  • Use of any of the following foods, drugs or treatments prior to the first administration: estrogen/progesterone replacement therapy, calcitonin, parathyroid hormone and its analogs, vitamin D supplements > 1000 IU/day, glucocorticoids (inhaled or topical glucocorticoids used more than 2 weeks before screening are allowed), anabolic steroids, calcitriol and its analogs, thiazide diuretics within 6 months prior to the first administration; bisphosphonates, fluoride for the treatment of osteoporosis within 12 months prior to the first administration; denosumab or any cathepsin K inhibitor within 18 months prior to the first administration; prior use of Romosozumab (including Evenity and other biosimilars); any prescription drugs or Chinese herbal medicines within 4 weeks prior to the first administration; any over-the-counter drugs and food supplements (including vitamins, calcium supplements, health food products, etc.) within 2 weeks prior to the first administration.
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  • Drug or substance abuse, alcoholism or heavy smoking: history of drug or substance abuse, or positive result in drug abuse screening at the time of screening; average weekly alcohol consumption > 14 units within 3 months prior to screening (1 unit ≈ 17.7 mL ethanol, i.e., 1 unit ≈ 360 mL beer with 5% alcohol content, or 45 mL Baijiu (liquor) with 40% alcohol content, or 150 mL wine with 12% alcohol content), or positive alcohol test result at screening, or inability to completely abstain from any food or beverage containing alcohol during the hospitalization period; average daily cigarette consumption > 5 sticks within 3 months prior to screening, or inability to completely abstain from any tobacco products during the hospitalization period; average daily caffeine intake > 500 mg within 3 months prior to screening (equivalent to 5 cups of tea or coffee, or 8 cans of soda or other caffeinated products).
  • Blood donation (including component blood donation) or blood loss ≥ 400 mL within 3 months prior to screening; blood donation (including component blood donation) or blood loss ≥ 200 mL or blood transfusion within 1 month prior to screening; or plan to donate blood or blood components during the study period or within 1 month after the end of the study.
  • Difficulty in blood collection or inability to tolerate multiple venipunctures; or a history of clinically significant needle phobia or hematophobia as judged by the investigator.
  • Vaccination with live vaccines, live attenuated vaccines or any vaccine containing live viral components within 3 months prior to screening; or plan to receive the above vaccines during the study period or within 1 month after the end of the study.
  • Severe trauma or major surgery requiring general anesthesia within 3 months prior to screening; or plan to undergo surgery (except for surgery under local anesthesia) within 3 months after the last administration.
  • Participation in any interventional clinical study (including investigational drugs or vaccines, as well as other clinical studies of the study drug or other cohorts of this study) and receipt of investigational drugs within 3 months prior to screening, or current participation in such studies.
  • Other diseases or medical histories that are clinically significant or may prevent the subject from completing the study, or other diseases or medical histories that may significantly alter drug absorption, metabolism or excretion, as judged by the investigator.
  • Any other reasons that make the subject unsuitable for participation in this study, as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The Second Hospital of Anhui Medical University Clinical Pharmacology Research Center

    Hefei, Anhui, 230601

Other trials in China

About this study

Official title: A Randomized, Open-Label, Single-Dose, Parallel-Controlled Biosimilarity Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Adult Chinese Subjects

Primary objective of this study is to evaluate the similarity in pharmacokinetic characteristics between SAL023 Injection and Italy-manufactured Evenity. Secondary objective is to assess the similarity in safety, pharmacodynamic and immunogenicity profiles of SAL023 Injection and Italy-manufactured Evenity.

Read the detailed description

This study adopts a randomized, open-label, single-dose, active-controlled, two-arm, parallel-group design.

The entire study will last approximately 16 weeks, consisting of a screening period, a dosing and inpatient observation period, and a follow-up period. A total of 118 healthy adult Chinese subjects are planned to be enrolled in the study and will be randomly assigned to the SAL023 group (Group A) and the Italy-manufactured Evenity group (Group B) at a ratio of 1:1, with 59 subjects in each group. All subjects will receive a single subcutaneous injection of either SAL023 or Italy-manufactured Evenity.

Eligible subjects will be admitted to the research center on Day -1 and undergo randomization. They will receive the required examinations on Day 10 after dosing, and will be discharged from the research center only after the investigator confirms their safety. After discharge, the subjects will return to the research center for regular follow-up visits in accordance with the study protocol.

Conditions
Osteoporosis
Being tested
SAL0123, Romosozumab
Keywords
Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, Biosimilarity Comparison
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAL0123Drug

    Dosage Form: Injection Specification: 105mg:1.17ml Dosage and Administration: 2 vials of 105 mg: 1.17 mL each, subcutaneous injection in the upper arm and abdomen Treatment Duration: Single subcutaneous injection of 2 vials on Day 1

  • RomosozumabDrug

    Dosage Form: Injection Specification: 105mg:1.17ml Dosage and Administration: 2 vials of 105 mg: 1.17 mL each, subcutaneous injection in the upper arm and abdomen Treatment Duration: Single subcutaneous injection of 2 vials on Day 1

Study groups in NCT07384104
Study groupRoleWhat they receive
Test GroupExperimentalDrug: SAL0123 105mg:1.17ml
Receives: Drug: SAL0123
Reference GroupActive comparatorDrug: Romosozumab 105mg:1.17ml
Receives: Drug: Romosozumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK parameters（ Cmax）

    Measured: Within a single dosing period ( from pre-dose up to 85 days post-dose)

  2. PK parameters（ AUCinf）

    Measured: Within a single dosing period ( from pre-dose up to 85 days post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start19 Oct 2025
  3. Primary completion5 Feb 2026 (estimated)
  4. Study completion5 Feb 2026 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384104
Sponsor's protocol ID
SAL023A102
Status last verified
Jan 2026
First submitted
13 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAL0123 and Romosozumab in people with Osteoporosis, run by Shenzhen Salubris Pharmaceuticals 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 6 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

PK parameters（ Cmax） (time frame: Within a single dosing period ( from pre-dose up to 85 days post-dose)). 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 NCT07384104.

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 3 Feb 2026.

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