Comparing HS-20090 and Xgeva® in Healthy Adults

A Dual-center, Randomized, Double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, Pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults

This study is testing a new injection called HS-20090 to see how it compares in safety and effects to the existing drug Xgeva® in healthy adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Male
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT05777109 on ClinicalTrials.gov

What this trial studies

This clinical trial is a phase I, dual-center, randomized, double-blind, and parallel-controlled study designed to evaluate the pharmacokinetic similarity, safety, and immunogenicity of HS-20090 compared to Xgeva® in healthy adult volunteers. Participants will receive a single subcutaneous injection of either HS-20090 or Xgeva®, and their responses will be monitored to assess how the two treatments compare in terms of drug absorption, effects on the body, and safety profiles. The study aims to gather preliminary data on the pharmacodynamic similarities between the two injections.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males aged 18 to 50 years, weighing between 55 kg and 75 kg, with a normal BMI.

Not a fit: Patients outside the specified age range, those with significant health issues, or individuals who do not meet the weight and BMI criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a new treatment option that may offer similar benefits to Xgeva® with potentially improved safety or efficacy.

How similar studies have performed: While this study is assessing a new treatment, similar studies comparing pharmacokinetics and safety of related drugs have shown promising results in the past.

Eligibility criteria

Inclusion Criteria:

* 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 and ≤50 years old(including the boundary value);
* Subjects weighing ≥ 55 kg and ≤ 75 kg (weight difference in a single center is controlled within 10 kg), with a BMI between 19.0 and 26.0 kg/m2 (BMI = weight (kg)/height2 (m2)) (including borderline values).
* The subject agrees to use effective contraception for at least 6 months from the screening date until after study dosing, and has no plans to have children or donate sperm within 6 months;
* Physical examination, vital signs, laboratory examination, chest X-ray, B-ultrasound and electrocardiogram are normal, or the above tests are abnormal without clinically significance and have no effect on the test as judged by the investigator;
* ECG examination: corrected QT interval (QTcF) \< 450 ms.

Exclusion Criteria:

* Occurred or suffering from osteomyelitis or ONJ (OsteoNecrosis of the Jaw) 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;
* Subjects with any previous or current clinically serious diseases such as circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric, and metabolic abnormalities or any other diseases that can interfere with the study results.
* Positive screening for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, Acquired Immune Deficiency Syndrome (AIDS) antibodies, and syphilis spirochete antibodies.
* Abnormal blood calcium: current hypocalcemia or hypercalcemia. Serum calcium outside the normal laboratory range; (Subjects should not apply calcium supplements for at least 8 hours prior to drawing blood for serum calcium screening assays.)
* previous use of RANKL inhibitors or osteoclastogenesis inhibitory factor.
* The subject is participating in another clinical study, or the first dose was administered less than 3 months after the last dose of the previous clinical study (or 5 half-lives of the study drug, whichever is longer).
* Average daily smoking ≥ 5 cigarettes in the 3 months prior to randomization.
* Prior history of alcohol abuse (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine), substance abuse or drug use.
* Positive substance abuse screening or/and alcohol breath test screening prior to study administration.
* Subjects who have donated blood within 3 months prior to administration, or have lost more than 400 ml of blood, or are scheduled to donate blood within 6 months.
* Subjects who have had a significant change in physical status within 6 months prior to administration, or who have been performing strenuous exercise.
* Subjects who, in the opinion of the investigator, have any factors that make participation in this trial inadvisable.

Where this trial is running

Haikou, Hainan

• Haikou People's Hospital — Haikou, Hainan, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoai He, Master — Haikou People's Hospital
• Study coordinator: Xiaoai He, Master

Conditions: Healthy, HS-20090, Pharmacokinetic, pharmacodynamics, Safety, Immunogenicity