Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
NCT ID: NCT05777109
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
180 participants
INTERVENTIONAL
2023-04-20
2024-04-05
Brief Summary
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Detailed Description
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The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.
The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile, observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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HS-20090
Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
HS-20090
A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
Xgeva®
Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
Xgeva®
Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
Interventions
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HS-20090
A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
Xgeva®
Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
MALE
Yes
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoai He, Master
Role: PRINCIPAL_INVESTIGATOR
Haikou People's Hospital
Wei Zhao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shandong First Medical University
Locations
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Haikou People's Hospital
Haikou, Hainan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-20090-102
Identifier Type: -
Identifier Source: org_study_id
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