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Healthy Male VolunteersPhase 1NCT04534582

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

A Phase 1 study testing HLX14, EU-Prolia® and US-Prolia® in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 2 drugs. Read more about this study

Who is it for?
Ages 28 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Volunteers
What is being tested?
HLX14, EU-Prolia® and US-Prolia®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
3 Nov 2020to 12 Sep 2023
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 28 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males aged> 28 and ≤ 65 years;
  • Body weight ≥ 50 kg, body mass index (BMI) = body weight (kg)/body height2 (m2), BMI ≥ 19 and ≤ 26 kg/m2;
  • With no disease history, or with abnormal prior medical history which has no effect on the trial as judged by the physician;
  • Normal or abnormal without clinical significance in physical examination, vital signs, ECG, chest imaging, clinical laboratory test, etc.;
  • Before the trial, sign the informed consent form (ICF) and have a full understanding of trial content, process, and possible adverse events (AEs); be able to complete the study as per protocol requirements.

Who cannot join

  • With a history of allergy to study drugs, calcium, and/or vitamin D, or with a history of allergy to drugs or others not suitable for participating in this study as judged by the investigators;
  • With the following clinically significant diseases (including but not limited to digestive system, kidney diseases, liver diseases, nervous diseases, blood system, endocrine system, tumor, respiratory system, immune diseases, mental diseases, cardiovascular and cerebrovascular diseases, or any condition that may affect bone metabolism);
  • With a history of upper respiratory tract infection and other acute infections within 2 weeks prior to screening;
  • Occurred or suffering from osteomyelitis or ONJ (Osteonecrosis of the jaw) previously.
  • The dental or jaw disease that is active, requiring oral surgery; or dental or oral surgery wounds have not healed; or planned for invasive dental surgery during the study.
  • Occurrence of fracture or bone-related surgery within 6 months prior to screening;
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  • With rash, scar, tattoo, etc. at administration site that may affect drug absorption;
  • Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
  • Use of any prescription drugs, over-the-counter (OTC) drugs, vitamin products, or traditional Chinese medicines within 28 days prior to screening;
  • Participation in any drug clinical trials and use of any investigational/comparator drugs within 3 months prior to screening;
  • Administration of the following drugs affecting bone metabolism:
  • Administration history of denosumab or its biosimilar products, romosozumab or its biosimilar products, cathepsin K inhibitors, diphosphonates, fluorides, or stronitum;
  • Administration of the following within 12 months before screening: parathyroid hormone or its derivatives, hormone replacement therapy (HRT), selective estrogen receptor modulators (SERM), tibolone, anabolic steroids, testosterone, androgen, and gonadotropin-releasing hormone agonists (GnRH-a);
  • Administration of any prescription drug or OTC drug within 6 months or 10 half-lives of drug elimination (whichever is the longer) before screening that may have impact on the objectives of the study at the discretion of the investigator, including but not limited to heparin, warfarin, anticonvulsants (excluding benzodiazepine), systemic ketoconazole, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors (PI), methotrexate (MTX), calcitonin, calcitriol, diuretics, and glucocorticoids for oral administration or injection (daily administration of ≥ 5 mg prednisone or equivalent drugs for more than 10 days);
  • Use of any biological products (excluding vaccine) or monoclonal antibodies within 6 months prior to screening;
  • Vaccination within 1 month prior to screening;
  • With a history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirit, or 100 mL of wine), or positive for alcohol breath test;
  • With a history of substance abuse or drug abuse, or positive for drug screen;
  • Positive for tobacco screen;
  • With significant changes in physical activity within 6 months prior to screening, or not agree to abstain from strenuous physical exercise during the trial;
  • Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody (TPPA);
  • Abnormal serum calcium level (beyond the laboratory reference range) during the screening;
  • Ear temperature > 37.5 °C during the screening period; and/or sitting systolic blood pressure (SBP) > 140 mmHg or < 90 mmHg, and/or diastolic blood pressure (DBP) > 90 mmHg or < 50 mmHg; and/or pulse rate > 100 beats/min or < 50 beats/min during the screening.
  • Clinically significant abnormal ECG or QTcF > 450 ms during screening, or with a prior history of clinically significant abnormal ECG;
  • Unwilling to take adequate contraceptive measures during the study.
  • Subjects who, in the opinion of the investigators, are not eligible to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital，Fudan University

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Randomised, Parallel, Single-Dose, Subcutaneous Injection, Phase I Clinical Study Of HLX14 Versus Prolia® (Denosumab) In Chinese Healthy Adult Male Subjects For Comparison In Pharmacokinetic Characteristics, Safety, And Immunogenicity

Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 2 drugs.

Part II of the study： This is a randomised, double-blind, four-arm, single-dose, subcutaneous injection, parallel-controlled study to evaluate the PK, PD, safety, tolerability, and immunogenicity between-group following a single subcutaneous injection of HLX14 or US, EU, CN-sourced Prolia®.

Being tested
HLX14, EU-Prolia®, US-Prolia®, CN-Prolia®

What participants receive

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

  • HLX14Drug

    healthy volunteers receive HLX14 (60mg) once

  • EU-Prolia®Drug

    healthy volunteers receive EU-Prolia® (60mg) once

  • US-Prolia®Drug

    healthy volunteers receive US-Prolia® (60mg) once

  • CN-Prolia®Drug

    healthy volunteers receive CN-Prolia® (60mg) once

Study groups in NCT04534582
Study groupRoleWhat they receive
Part I: HLX14 groupExperimentalPart I: HLX14 are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: HLX14
Part I: EU-Prolia® groupActive comparatorPart I: EU-Prolia® are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: EU-Prolia®
Part II: HLX14 groupExperimentalPart II: HLX14 are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: HLX14
Part II: EU-Prolia® groupActive comparatorPart II: EU-Prolia® are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: EU-Prolia®
Part II: US-Prolia® groupActive comparatorPart II: US-Prolia® are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: US-Prolia®
Part II: CN-Prolia® groupActive comparatorPart II: CN-Prolia® are given subcutaneous injection at a single dose of 60 mg.
Receives: Drug: CN-Prolia®

What is being measured

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

  1. AUC(0-t)

    Area under the serum concentration-time curve from time 0 to the last concentration-quantifiable time t of denosumab

    Measured: from 0 to day 274

  2. Cmax

    Maximum serum concentration following administration of denosumab

    Measured: from 0 to day 274

  3. AUC0-inf

    Area under the serum concentration-time curve from time 0 to infinity

    Measured: from 0 to day 274

Secondary outcomes (12)

  1. Tmax

    Time to reach maximum serum concentration following administration

    Measured: from 0 to day 274

  2. CL/F

    Total clearance

    Measured: from 0 to day 274

  3. λz

    Apparent terminal elimination rate constant

    Measured: from 0 to day 274

  4. t1/2

    Elimination half life

    Measured: from 0 to day 274

  5. Vd/F

    Apparent volume of distribution

    Measured: from 0 to day 274

  6. %AUCex

    Area extrapolated from time to infinity as a percentage of total AUC0-inf

    Measured: from 0 to day 274

  7. MRT

    Mean residence time

    Measured: from 0 to day 274

  8. AUC0-28d and AUC0-112d

    Area under the drug concentration-time curve from day 0 to day 28 (4 weeks) and from day 0 to day 112 (16 weeks)

    Measured: from 0 to day 112

  9. AUEC0-t

    Area under the effect-time curve from time zero to last time of quantifiable concentration of serum CTX1

    Measured: from 0 to day 274

  10. Imin

    Minimum observed concentration of serum CTX1

    Measured: from 0 to day 274

  11. Imax

    Maximum percent inhibition of serum CTX1

    Measured: from 0 to day 274

  12. Tmin

    Time to reach Imin of serum CTX1

    Measured: from 0 to day 274

Timeline

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

  1. First posted1 Sep 2020
  2. Study start3 Nov 2020
  3. Primary completion12 Sep 2023
  4. Study completion12 Sep 2023

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534582
Sponsor's protocol ID
HLX14-001
Status last verified
Mar 2024
First submitted
27 Aug 2020
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Li N, Chu N, Zhu L, Wu X, Wei Q, Wang J, Hu X, Yu H, Wang Q, Yuan W, Huang K, Zhang J. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study. Clin Transl Sci. 2024 Dec;17(12):e70089. doi: 10.1111/cts.70089.

    PubMed 39700054

  • American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. No abstract available.

    PubMed 35132630

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX14, EU-Prolia® and US-Prolia® in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech 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 5 inclusion and 26 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: finished, as of the sponsor's last update on 20 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-t) (time frame: from 0 to day 274). The study lists 3 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 NCT04534582, which also lists 2 linked publications.

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 20 Jan 2025.

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