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RecruitingNCT06525636Updated Nov 6, 2026

A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia

A Phase 1/2 interventional study of KK8123 in X-linked Hypophosphatemia, sponsored by Kyowa Kirin Co., Ltd.. Recruiting at 10 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Updated Nov 6, 2026Site recruiting status changedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.

Read the detailed description

Study 8123-001 is a Phase 1/2, multicenter, open-label, dose-escalation study to assess the safety, tolerability, PK and PD of KK8123, with an optional safety extension period. This study is comprised of a Screening Period followed by Part 1 and Part 2. The Screening Period will last up to 35 days (including obtaining informed consent). Part 1 is a Dose Escalation Period consisting of a nominal (planned) Treatment Period (all cohorts) followed by an Observation Period, and Part 2 is an optional Extension Period.

02

Conditions studied

  • X-linked Hypophosphatemia

Keywords

  • Gene Mutation
  • Bone Disease
  • Metabolic Disease
  • Musculoskeletal Disease,
  • Rare Disease
  • Hypophosphatemia
  • Familial Renal Tubular Transport
  • Inborn Errors
  • Kidney Diseases
03

In context

Familial Hypophosphatemic Rickets

49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.

This study's planned enrollment of 39 is above the median of 28 across 29 interventional studies indexed under Familial Hypophosphatemic Rickets.

Browse Familial Hypophosphatemic Rickets studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.

Browse Kyowa Kirin Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Part 1: Inclusion Criteria:

    1. Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
    2. Body weight is at least 40 kg.
    3. Diagnosed with XLH (as documented by the investigator).
    4. Have a value of fasting serum phosphorus \< 2.5 mg/dL (0.81 mmol/L) at Screening.
    5. Have a value of renal TmP/ \< 2.5 mg/dL (0.81 mmol/L) at Screening.
    6. eGFR ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration equation [Inker, 2021]) at Screening.
    7. Have a corrected serum calcium level \< 10.8 mg/dL (2.7 mmol/L) at Screening.
    8. Provide a signed ICF.
    9. Agree not to change diet and exercise regimen from one week prior to dosing to end of study.
    10. Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female participants only).
    11. If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to the Screening visit, and be willing to maintain medications at the same stable dose(s) and schedule throughout the clinical trial. The dose must not exceed 60 mg oral morphine equivalents/day.

    12. Be willing to use a method of following local country guidelines while participating in the study and for 30 weeks after the last dose (all sexually active participants of ).

      Women of non-childbearing potential are defined as permanently sterile (i.e., due to tubal ligation at least one year before Screening, hysterectomy or bilateral oophorectomy) or (defined as at least 12 months post cessation of menses without an alternative medical cause).

      Postmenopausal status of female participants will be confirmed with a Screening serum follicle-stimulating hormone level >40 mIU/mL.

    13. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments.

Exclusion criteria

Exclusion Criteria:

  • Part 1: Exclusion Criteria:

    1. For XLH participants previously treated with the applicable prior therapy, use within the protocol defined prior to ICF signature.
    2. Prior history of positive test for antibody, positive test for surface antigen, and/or virus antibody at Screening.
    3. History of to any ingredient of any therapeutic monoclonal antibody.
    4. Have an active infection.
    5. Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.
    6. Uncontrolled diabetes mellitus at Screening.
    7. History of known immunodeficiency.
    8. History of alcoholism or drug abuse.
    9. History of donation of blood within 60 days prior to Screening.
    10. Use of any IP or medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
    11. Use of any therapeutic mAb within 90 days prior to Screening.
    12. Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and/or systemic within 14 days prior to Screening. If the participant takes any of these medications, a washout period of 14 days will be required after signing the ICF and before any other screeening assessments begin.
    13. Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Screening and for the duration of the study.
    14. Use of denosumab within 6 months prior to Screening.
    15. Use of oral bisphosphonates in the 2 years prior to Screening.
    16. Use of teriparatide or abaloparatide in the 2 months prior to Screening.
    17. Plasma iPTH ≥ 2.5 × at Screening.
    18. Planned or recommended orthopedic surgery during the study.
    19. History of traumatic fracture or orthopedic surgery within 6 months prior to Screening.
    20. Participants who are lactating.
    21. Current active and symptomatic COVID-19 infection immediately prior to study treatment.
    22. Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study, or that would confound safety or interpretation of results.

Part 2: Inclusion Criteria:

  1. Completion of relevant cohort in Part 1 of the study.
  2. Provide a signed after the nature of Part 2 of the study has been explained.
  3. Body weight is at least 40 kg.
  4. Negative pregnancy test at Screening of Part 2 and willing to have additional pregnancy tests until the end of the study (female participants only).
  5. If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to Week 0 of Part 2, and be willing to maintain medications at the same stable dose(s) and schedule throughout the study. The dose must not exceed 60 mg oral morphine equivalents/day.
  6. Be willing to use a method of following local country guidelines while participating in the study and for 30 weeks after the last dose (all sexually active participants of ). Women of non-childbearing potential are defined as permanently sterile (i.e., due to tubal ligation at least one year before Screening, hysterectomy or bilateral oophorectomy) or (defined as at least 12 months post cessation of menses without an alternative medical cause). Postmenopausal status of female participants will be confirmed with a Week 0 serum follicle-stimulating hormone level >40 mIU/mL.
  7. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with all the assessments.
  8. For participants who complete the Part 1 EoS visit more than 30 days before starting Part 2 Week 0, ≥ 60 mL/min at Screening.
  9. For participants who complete the Part 1 EoS visit more than 30 days before starting Part 2 Week 0, have a corrected serum calcium level of \< 10.8 mg/dl (2.7 mmol/L) at Screening.

Part 2: Exclusion Criteria:

  1. Use of the applicable prior therapy following completion of Part 1 of the study.
  2. Have an active infection.
  3. Donation of blood within 60 days prior to Week 0 of Part 2.
  4. Use of any investigational product other than KK8123, or investigational medical device, within 30 days prior to Week 0 of Part 2, or requirement for any investigational agent prior to completion of all scheduled study assessments.
  5. Use of any therapeutic mAb other than KK8123 within 90 days prior to Week 0 of Part 2.
  6. Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and/or systemic corticosteroids within 14 days prior to Week 0 of Part 2.
  7. Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Week 0 of Part 2.
  8. Use of oral bisphosphonates following completion of Part 1 of the study.
  9. Use of teriparatide or abaloparatide in the 2 months prior to Week 0 of Part 2.
  10. Planned or recommended orthopedic surgery during the study.
  11. History of traumatic fracture or orthopedic surgery within 6 months prior to Week 0 of Part 2.
  12. Participants who are lactating.
  13. Current active and symptomatic COVID-19 infection, or a history of suffering any long-term sequalae from COVID-19 infection.
  14. Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • Experimental
    Part 1: Cohort 1

    Low Dose of KK8123

    Drug: KK8123

  • Experimental
    Part 1: Cohort 2

    Mid dose of KK8123

    Drug: KK8123

  • Experimental
    Part 1: Cohort 3

    High dose of KK8123

    Drug: KK8123

  • Experimental
    Part 1: Cohort 4A

    Mid-High dose of KK8123

    Drug: KK8123

  • Experimental
    Part 1: Cohort 4B

    Mid-High dose of KK8123

    Drug: KK8123

  • Experimental
    Part 2: Extension Phase

    Mid-High dose of KK8123

    Drug: KK8123

Interventions

  • DrugKK8123

    Subcutaneous administration

06

What researchers measure

Primary outcomes

  1. Part 1: Number of participants with TEAEs

    Time frame: For up to 48 weeks.

  2. Part 1: Percentage of participants with TEAEs

    Time frame: For up to 48 weeks.

  3. Part 2: Number of participants with TEAEs

    Time frame: For up to 48 weeks.

  4. Part 2: Percentage of participants with TEAEs

    Time frame: For up to 48 weeks.

  5. Part 1: Change from baseline for haematology laboratories values

    Time frame: For up to 48 weeks.

  6. Part 2: Change from baseline for haematology laboratories values

    Time frame: For up to 48 weeks.

  7. Part 1: Change from baseline for clinical chemistry laboratories values

    Time frame: For up to 48 weeks.

  8. Part 2: Change from baseline for clinical chemistry laboratories values

    Time frame: For up to 48 weeks.

  9. Part 1: Change from baseline in continuous variables for FSH

    Time frame: For up to 48 weeks.

  10. Part 2: Change from baseline in continuous variables for FSH

    Time frame: For up to 48 weeks.

  11. Part 1: Change from baseline in continuous variables for estradiol

    Time frame: For up to 48 weeks.

  12. Part 2: Change from baseline in continuous variables for estradiol

    Time frame: For up to 48 weeks.

  13. Part 1: Change from baseline in continuous variables for temperature

    Time frame: For up to 48 weeks.

  14. Part 2: Change from baseline in continuous variables for temperature

    Time frame: For up to 48 weeks.

  15. Part 1: Change from baseline in continuous variables for pulse rate

    Time frame: For up to 48 weeks.

  16. Part 2: Change from baseline in continuous variables for pulse rate

    Time frame: For up to 48 weeks.

  17. Part 1: Change from baseline in continuous variables for respiratory rate

    Time frame: For up to 48 weeks.

  18. Part 2: Change from baseline in continuous variables for respiratory rate

    Time frame: For up to 48 weeks.

  19. Part 1: Change from baseline in continuous variables for systolic and diastolic blood pressure

    Time frame: For up to 48 weeks.

  20. Part 2: Change from baseline in continuous variables for systolic and diastolic blood pressure

    Time frame: For up to 48 weeks.

  21. Part 1: Change from baseline in continuous variables for QT

    Time frame: For up to 48 weeks.

  22. Part 2: Change from baseline in continuous variables for QT

    Time frame: For up to 48 weeks.

  23. Part 1: Change from baseline in continuous variables for QTc

    Time frame: For up to 48 weeks.

  24. Part 2: Change from baseline in continuous variables for QTc

    Time frame: For up to 48 weeks.

  25. Part 1: Change from baseline in continuous variables for QTCF

    Time frame: For up to 48 weeks.

  26. Part 2: Change from baseline in continuous variables for QTCF

    Time frame: For up to 48 weeks.

  27. Part 1: Change from baseline in continuous variables for QRS

    Time frame: For up to 48 weeks.

  28. Part 2: Change from baseline in continuous variables for QRS

    Time frame: For up to 48 weeks.

  29. Part 1: Change from baseline in continuous variables for heart rate

    Time frame: For up to 48 weeks.

  30. Part 2: Change from baseline in continuous variables for heart rate

    Time frame: For up to 48 weeks.

  31. Part 1: The presence or absence of abnormality on ectopic mineralization, any sign of left ventricular hypertrophy or heart failures before and after administration of KK8123 on Echocardiogram

    Time frame: For up to 48 weeks.

  32. Part 2: The presence or absence of abnormality on ectopic mineralization, any sign of left ventricular hypertrophy or heart failures before and after administration of KK8123 on Echocardiogram

    Time frame: For up to 48 weeks.

  33. Part 1: Before and after administration presented at each time point in categorical variables for renal ultrasound

    Time frame: For up to 48 weeks.

  34. Part 2: Before and after administration presented at each time point in categorical variables for renal ultrasound

    Time frame: For up to 48 weeks.

  35. Part 1: KK8123 concentrations by maximum plasma concentration (Cmax)

    Time frame: For up to 48 weeks.

  36. Part 2: KK8123 concentrations by maximum plasma concentration (Cmax)

    Time frame: For up to 48 weeks.

  37. Part 1: KK8123 concentrations by maximum serum concentration (tmax)

    Time frame: For up to 48 weeks.

  38. Part 2: KK8123 concentrations by maximum serum concentration (tmax)

    Time frame: For up to 48 weeks.

  39. Part 1: KK8123 concentrations by area under the serum concentration time curve from zero to last detectable time point (AUClast)

    Time frame: For up to 48 weeks.

  40. Part 2: KK8123 concentrations by area under the serum concentration time curve from zero to last detectable time point (AUClast)

    Time frame: For up to 48 weeks.

  41. Part 1: KK8123 concentrations by the area under the serum concentration time curve from zero to infinity (AUC00-inf)

    Time frame: For up to 48 weeks.

  42. Part 2: KK8123 concentrations by the area under the serum concentration time curve from zero to infinity (AUC00-inf)

    Time frame: For up to 48 weeks.

  43. Part 1: KK8123 concentrations by apparent volume of distribution (V/F)

    Time frame: For up to 48 weeks.

  44. Part 2: KK8123 concentrations by apparent volume of distribution (V/F)

    Time frame: For up to 48 weeks.

  45. Part 1: KK8123 concentrations by terminal half-life (t1/2)

    Time frame: For up to 48 weeks.

  46. Part 2: KK8123 concentrations by terminal half-life (t1/2)

    Time frame: For up to 48 weeks.

  47. Part 1: KK8123 concentrations by apparent clearance (CL/F)

    Time frame: For up to 48 weeks.

  48. Part 2: KK8123 concentrations by apparent clearance (CL/F)

    Time frame: For up to 48 weeks.

  49. Part 1: KK8123 concentrations by maximum plasma concentration steady state (Cmax,ss)

    Time frame: For up to 48 weeks.

  50. Part 2: KK8123 concentrations by maximum plasma concentration steady state (Cmax,ss)

    Time frame: For up to 48 weeks.

  51. Part 1: KK8123 concentrations by time to maximum serum concentration steady state (tmax,ss)

    Time frame: For up to 48 weeks.

  52. Part 2: KK8123 concentrations by time to maximum serum concentration steady state (tmax,ss)

    Time frame: For up to 48 weeks.

  53. Part 1: KK8123 concentrations over time by area under the serum concentration curve within a dosing interval at steady state (AUCtau,ss)

    Time frame: For up to 48 weeks.

  54. Part 2: KK8123 concentrations over time by area under the serum concentration curve within a dosing interval at steady state (AUCtau,ss)

    Time frame: For up to 48 weeks.

  55. Part 1: KK8123 concentrations by time to steady state

    Time frame: For up to 48 weeks.

  56. Part 2: KK8123 concentrations by time to steady state

    Time frame: For up to 48 weeks.

  57. Part 1: KK8123 concentrations by accumulation ratio

    Time frame: For up to 48 weeks.

  58. Part 2: KK8123 concentrations by accumulation ratio

    Time frame: For up to 48 weeks.

  59. Part 1: To evaluate the effect of single and multiple SC administrations of KK8123 on serum phosphorus levels

    Time frame: For up to 48 weeks.

  60. Part 2: To evaluate the effect of multiple SC administrations of KK8123 on serum phosphorus levels

    Time frame: For up to 48 weeks.

Secondary outcomes

  1. Part 1: ADA positivity titers to be assessed by absolute number

    Time frame: For up to 48 weeks.

  2. Part 1: ADA positivity titers to be assessed by percentage

    Time frame: For up to 48 weeks.

  3. Part 2: ADA positivity titers to be assessed by absolute number

    Time frame: For up to 48 weeks.

  4. Part 2: ADA positivity titers to be assessed by percentage

    Time frame: For up to 48 weeks.

07

Study locations

9 of 10 sites recruiting
  • University of California - San Francisco
    San Francisco, California 94158, United States
    Recruiting
  • Yale Center for XLH/ Yale University School of Medicine
    New Haven, Connecticut 06510, United States
    Recruiting
    • Elizabeth Olear, MS, MA · Contactycxlhinfo@yale.edu · 203-785-6779
    • Clemens Bergwitz, MD · Principal investigator
  • Indiana University School of Medicine University Hospital
    Indianapolis, Indiana 46202, United States
    Recruiting
    • Fridah Mbatia · Contactfwmbatia@iu.edu · 317-278-6123
    • Erik Imel, MD · Principal investigator
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Not yet recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    Recruiting
    • Margo Black, MSN RN CCRP · Contactmargo.black@vumc.org · 615-343-5846
    • Kathryn Dahir, MD · Principal investigator
  • Bone Research and Education Center
    Oakville, Ontario, Canada
    Recruiting
  • Hoptial Bictre
    Le Kremlin-Bicêtre, Paris 94275, France
    Recruiting
    • Guilaine Guiose · Contactguilaine.guiose@aphp.fr · 33 1 45 21 74 53 Dect : 24119
    • Peter Kamenicky, MD · Principal investigator
  • Institute of Osteology and Biomechanics (IOBM)
    Hamburg, 22529, Germany
    Recruiting
    • Alison Schoen · ContactAli.Schoen@uke.de · 0152 2281 6702
    • Ralf Oheim, MD · Principal investigator
  • Universitaetsklinikum Wurzburg
    Würzburg, 97074, Germany
    Recruiting
    • Jasmin Baumann · Contactjasmin.baumann@klh.de · 0049 931/803-3590
    • Lothar Seefried, MD · Principal investigator
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
Bone Research and Education Center is now Recruiting
Nov 6, 2026
Primary completion
May 21, 2029→Jun 14, 2030
Nov 6, 2026
Study completion
May 21, 2029→Jun 14, 2030
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Bone Research and Education Center is now Recruiting
    Primary completion May 21, 2029→Jun 14, 2030
    Study completion May 21, 2029→Jun 14, 2030
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06525636
Lead sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Kirin, Inc.
Responsible party
Sponsor
First posted
Jul 29, 2024
Start date
Oct 9, 2024
Primary completion
Jun 14, 2030 (estimated)
Completion
Jun 14, 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Kyowa Kirin
Contact
KKD.Clintrial.82@kyowakirin.com
609-919-1100
Kyowa Kirin
study chair · Kyowa Kirin, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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