Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
NCT05777109
Phase
Phase 1
Recruitment status
Unknown
Participants
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Start date
2023-04-20
Number of sites
- 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
- Short title
- Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-04-05
- First posted
- 2023-03-21
- Registry last updated
- 2023-08-23
- Primary completion date
- 2024-04-05
- Start date
- 2023-04-20
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05777109
- ClinicalTrials.gov ID
- NCT05777109
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
AUC0-∞
Timeframe: 155days
The area under the curve from time 0 extrapolated to infinite time
Cmax
Timeframe: 155days
Maximum concentration
AUC0-t
Timeframe: 155days
Area under the plasma concentration-time curve
Tmax
Timeframe: 155days
Time to reach Cmax
t1/2z
Timeframe: 155days
Terminal half-life
Vz/F
Timeframe: 155days
Apparent volume of distribution
CLz/F
Timeframe: 155days
Apparent clearance
Serum type 1 C-telopeptide(CTX1)
Timeframe: 155days
explore the pharmacodynamic profile by detecting the serum concentration of CTX1
Imin
Timeframe: 155days
The minimum observed concentration
TEmax
Timeframe: 155days
Time to reach the maximum inhibition rate
Emax
Timeframe: 155days
Maximum observed inhibition rate
AUEC0-t
Timeframe: 155days
Area under the plasma effect-time curve from time zero to last time of quantifiable concentrationthe
Adverse events(AE)
Timeframe: 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.
Antidrug antibody(ADA):
Timeframe: 155days
percentage of subjects positive for antidrug antibody
Neutralizing antibody(Nab)
Timeframe: 155days
percentage of subjects positive for Nab
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- Haikou People's HospitalHaikou, ChinaRecruiting
Sources for sites