Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

NCT05777109 | Unknown Phase 1 DMC

• 1 other identifier: HS-20090-102
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

HS-20090; Pharmacokinetic; pharmacodynamics; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• AUC0-∞

  The area under the curve from time 0 extrapolated to infinite time

  155days

• Cmax

  Maximum concentration

  155days

Secondary Outcomes (13)

• AUC0-t

  155days

• Tmax

  155days

• t1/2z

  155days

• Vz/F

  155days

• CLz/F

  155days

Study Arms (2)

HS-20090

EXPERIMENTAL

Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day

Drug: HS-20090

Xgeva®

ACTIVE COMPARATOR

Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day

Drug: Xgeva®

Interventions

HS-20090 DRUG

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Also known as: Recombinant human anti-RANKL monoclonal antibody injection

HS-20090

Xgeva® DRUG

Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Also known as: Denosumab Injection

Xgeva®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Haikou People's Hospital

Haikou, Hainan, 570208, China

RECRUITING

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaoai He, Master

  Haikou People's Hospital

  PRINCIPAL INVESTIGATOR

• Wei Zhao, Ph.D

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoai He, Master

CONTACT

086-15008971099; 15008971099@126.com

Wei Zhao, Ph.D

CONTACT

086-15131190710; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: April 20, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)