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

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ClinicalTrials.gov Identifier: NCT04534582
Recruitment Status : Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Tracking Information
First Submitted Date  ICMJE August 27, 2020
First Posted Date  ICMJE September 1, 2020
Last Update Posted Date September 1, 2020
Estimated Study Start Date  ICMJE September 20, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • AUC(0-t) [ Time Frame: from 0 to day 183 ]
    Area under the serum concentration-time curve from time 0 to the last concentration-quantifiable time t of denosumab
  • Cmax [ Time Frame: from 0 to day 183 ]
    Maximum serum concentration following administration of denosumab
  • AUC0-inf [ Time Frame: from 0 to day 183 ]
    Area under the serum concentration-time curve from time 0 to infinity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Tmax [ Time Frame: from 0 to day 183 ]
    Time to reach maximum serum concentration following administration
  • CL/F [ Time Frame: from 0 to day 183 ]
    Total clearance
  • λz [ Time Frame: from 0 to day 183 ]
    Apparent terminal elimination rate constant
  • t1/2 [ Time Frame: from 0 to day 183 ]
    Elimination half life
  • Vd/F [ Time Frame: from 0 to day 183 ]
    Apparent volume of distribution
  • AUEC0-t [ Time Frame: from 0 to day 183 ]
    Area under the effect-time curve from time zero to last time of quantifiable concentration of Serum CTX1
  • Imin [ Time Frame: from 0 to day 183 ]
    Minimum observed plasma concentration of Serum CTX1
  • Imax [ Time Frame: from 0 to day 183 ]
    Maximum Percent Inhibition of Serum CTX1
  • Tmin [ Time Frame: from 0 to day 183 ]
    Time to reach Imin of Serum CTX1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Volunteers
Intervention  ICMJE
  • Drug: HLX14
    healthy volunteers receive HLX14 (60mg) once
  • Drug: EU-Prolia®
    healthy volunteers receive EU-Prolia® (60mg) once
Study Arms  ICMJE
  • Experimental: HLX14 group
    HLX14 are given subcutaneous injection at a single dose of 60 mg.
    Intervention: Drug: HLX14
  • Active Comparator: EU-Prolia® group
    EU-Prolia® are given subcutaneous injection at a single dose of 60 mg.
    Intervention: Drug: EU-Prolia®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2021
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males aged ≥ 18 and ≤ 65 years;
  2. Body weight ≥ 50 kg, body mass index (BMI) = body weight (kg)/body height2 (m2), BMI ≥ 19 and ≤ 26 kg/m2;
  3. With no disease history, or with abnormal prior medical history which has no effect on the trial as judged by the physician;
  4. Normal or abnormal without clinical significance in physical examination, vital signs, ECG, chest imaging, clinical laboratory test, etc.;
  5. 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.

Exclusion Criteria:

  1. 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;
  2. 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, or cardiovascular and cerebrovascular diseases);
  3. With a history of upper respiratory tract infection and other acute infections within 2 weeks prior to screening;
  4. 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.
  5. With rash, scar, tattoo, etc. at administration site that may affect drug absorption;
  6. Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
  7. Use of any prescription drugs, over-the-counter drugs, vitamin products, or traditional Chinese medicines within 28 days prior to screening;
  8. Participation in any drug clinical trials and use of any investigational/comparator drugs within 3 months prior to screening;
  9. Administration of drugs affecting bone metabolism within 6 months before participating in this study, including but not limited to: bisphosphonates, fluoride, calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (> 1000 IU/day), glucocorticoids, anabolic steroids, calcitriol, and diuretics;
  10. Use of any biological products or monoclonal antibodies within 6 months prior to screening;
  11. 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;
  12. With a history of substance abuse or drug abuse, or positive for drug screen;
  13. Positive for tobacco screen;
  14. With significant changes in physical activity within 6 months prior to screening, or not agree to abstain from strenuous physical exercise during the trial;
  15. Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody;
  16. Abnormal serum calcium level (beyond the laboratory reference range) during the screening;
  17. Body temperature > 37.5 °C; 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.
  18. Clinically significant abnormal ECG or QTcF > 450 ms during screening, or with a prior history of clinically significant abnormal ECG;
  19. Unwilling to take adequate contraceptive measures from screening to 6 months after the administration of study drugs. See Appendix 2 for specific contraceptive measures;
  20. Subjects who, in the opinion of the investigators, are not eligible to participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chaoming Ma, bachelor 021-33395790 Chaoming_Ma@henlius.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04534582
Other Study ID Numbers  ICMJE HLX14-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Henlius Biotech
Study Sponsor  ICMJE Shanghai Henlius Biotech
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jing Zhang Huashan Hospital
PRS Account Shanghai Henlius Biotech
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP