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HealthyPhase 1NCT05777109

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

A Phase 1 study testing HS-20090 and Xgeva® in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
HS-20090 and Xgeva®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
20 Apr 2023to 5 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Xiaoai He, Master contact

086-15008971099

15008971099@126.com

Wei Zhao, Ph.D contact

086-15131190710

zhao4wei2@hotmail.com

China1 site, 1 recruiting

  • Haikou People's Hospital

    Haikou, Hainan, 570208

    Xiaoai He, Master, 086-15008971099, 15008971099@126.com

    Recruiting

Other trials in China

About this study

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

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

Read the detailed description

This is a phase I, dual-center, randomized, double-blind and parallel group clinical trial .

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
Healthy
Being tested
HS-20090, Xgeva®
Keywords
HS-20090, Pharmacokinetic, pharmacodynamics, Safety, Immunogenicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20090Drug

    Also called Recombinant human anti-RANKL monoclonal antibody injection

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

  • Xgeva®Drug

    Also called Denosumab Injection

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

Study groups in NCT05777109
Study groupRoleWhat they receive
HS-20090ExperimentalSubcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
Receives: Drug: HS-20090
Xgeva®Active comparatorSubcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
Receives: Drug: Xgeva®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-∞

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

    Measured: 155days

  2. Cmax

    Maximum concentration

    Measured: 155days

Secondary outcomes (13)

  1. AUC0-t

    Area under the plasma concentration-time curve

    Measured: 155days

  2. Tmax

    Time to reach Cmax

    Measured: 155days

  3. t1/2z

    Terminal half-life

    Measured: 155days

  4. Vz/F

    Apparent volume of distribution

    Measured: 155days

  5. CLz/F

    Apparent clearance

    Measured: 155days

  6. Serum type 1 C-telopeptide(CTX1)

    explore the pharmacodynamic profile by detecting the serum concentration of CTX1

    Measured: 155days

  7. Imin

    The minimum observed concentration

    Measured: 155days

  8. TEmax

    Time to reach the maximum inhibition rate

    Measured: 155days

  9. Emax

    Maximum observed inhibition rate

    Measured: 155days

  10. AUEC0-t

    Area under the plasma effect-time curve from time zero to last time of quantifiable concentrationthe

    Measured: 155days

  11. Adverse events(AE)

    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.

    Measured: 155days

  12. Antidrug antibody(ADA):

    percentage of subjects positive for antidrug antibody

    Measured: 155days

  13. Neutralizing antibody(Nab)

    percentage of subjects positive for Nab

    Measured: 155days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start20 Apr 2023
  3. Primary completion5 Apr 2024 (estimated)
  4. Study completion5 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777109
Sponsor's protocol ID
HS-20090-102
Status last verified
Aug 2023
First submitted
8 Mar 2023
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20090 and Xgeva® in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaoai He, Master (086-15008971099, 15008971099@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-∞ (time frame: 155days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05777109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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