Clinical trial NCT04940845: Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Keywords: osteoporosis，postmenopausal
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 174
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
3. Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;
4. Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria:

1. 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;
2. Serum calcium levels are outside the normal range of the laboratory.
3. 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.
4. 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).
5. 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

Primary outcomes:
measure: Area under the plasma concentration-infinity curve (AUC0-∞ )
timeFrame: 155days
measure: Cmax
timeFrame: 155days
Secondary outcomes:
measure: Adverse events(AE)
timeFrame: 155days
measure: ADA
timeFrame: 155days
measure: Nab
timeFrame: 155days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technoogy
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technoogy
name: Dong Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huazhong University of Science and Technoogy
name: Xiuhua Ren, Master
role: PRINCIPAL_INVESTIGATOR
References: