Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Phase 1

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: HS-20090-2; Drug: Prolia

• Registration Number: NCT04940845
• Lead Sponsor: Shanghai Hansoh Biomedical Co., Ltd

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.

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-28
• Study Start: 2021-07-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-20090-2	HS-20090-2	-
Prolia®	Prolia	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-infinity curve (AUC0-∞ )	155days	Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.
Cmax	155days	maximum concentration

Secondary Outcome Measures

Name	Time	Method
Adverse events(AE)	155days	The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
ADA	155days	percentage of subjects positive for antidrug antibody
Nab	155days	percentage of subjects positive for Nab

Trial Locations

Locations (1)

Huazhong University of Science and Technoogy; 🇨🇳 Wuhan, Hubei, China