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A first-in-human study of KK8123 in adults with X-linked hypophosphatemia
EU CTIS ID: 2023-509390-23-00
What this study is testing
Part 1: to assess the safety and tolerability of KK8123 and to characterize the PK profile of KK8123. Part 2: to evaluate the safety and tolerability of KK8123 after multiple SC dosing.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
- 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.
- WOCBP who are sexually active must be willing to use a method of contraception following local country guidelines while participating in the study and for 30weeks after the last dose.
- 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.
- Diagnosed with XLH (as documented by the investigator).
- Have a value of fasting serum phosphorus < 2.5 mg/dL (0.81 mmol/L) at Screening.
You likely can't join if
- For XLH patients previously treated with other drugs, use of them within 7 months prior to ICF signature.
- Part 2: Planned or recommended orthopedic surgery during the study.
- Part 2: History of traumatic fracture or orthopedic surgery within 6 months prior to Week 0 of Part 2.
- Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.
- Part 2: Current active and symptomatic COVID-19 infection, or a history of suffering any long-term sequalae from COVID-19 infection.
- Part 2: 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.
See the full eligibility criteria
Who can join
- Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
- 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.
- WOCBP who are sexually active must be willing to use a method of contraception following local country guidelines while participating in the study and for 30weeks after the last dose.
- 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.
- Diagnosed with XLH (as documented by the investigator).
- Have a value of fasting serum phosphorus < 2.5 mg/dL (0.81 mmol/L) at Screening.
- Have a value of renal TmP/GFR < 2.5 mg/dL (0.81 mmol/L) at Screening.
- eGFR ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration equation) at Screening.
- Have a corrected serum calcium level < 10.8 mg/dL (2.7 mmol/L) at Screening.
- Body is weight at least 40 kg.
- Part 2: Body is weight at least 40 kg
- Provide a signed ICF after the nature of the study has been explained, and prior to any research-related procedures initiation.
- Part 2: WOCBP who are sexually active must be willing to use a method of contraception following local country guidelines while participating in the study and for 30weeks after the last dose.
- Agree not to change diet and exercise regimen from one week prior to dosing to end of study.
- Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female participants only).
- Part 2: Completion of relevant cohort in Part 1 of the study.
- Part 2: Provide a signed informed consent after the nature of Part 2 of the study has been explained.
- Part 2: Negative pregnancy test at Screening of Part 2 and be willing to have additional pregnancy tests during the study.
- Part 2: If taking chronic pain medications, must be on a stable regimen and be willing to maintain medications at the same stable dose(s) and schedule throughout the study.
- Part 2: 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.
What rules you out
- For XLH patients previously treated with other drugs, use of them within 7 months prior to ICF signature.
- Part 2: Planned or recommended orthopedic surgery during the study.
- Part 2: History of traumatic fracture or orthopedic surgery within 6 months prior to Week 0 of Part 2.
- Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.
- Part 2: Current active and symptomatic COVID-19 infection, or a history of suffering any long-term sequalae from COVID-19 infection.
- Part 2: 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.
- Use of any therapeutic mAb within 90 days prior to Screening.
- Planned or recommended orthopedic surgery during the study.
- 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 Screening.
- Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Screening and for the duration of the study.
- Use of denosumab within 6 months prior to Screening.
- Part 2: 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.
- Use of oral bisphosphonates in the 2 years prior to Screening.
- Use of teriparatide or abaloparatide in the 2 months prior to Screening.
- Prior history of positive test for human immunodeficiency virus antibody, positive test for hepatitis B surface antigen, and/or hepatitis C virus antibody at Screening.
- History of traumatic fracture or orthopedic surgery within 6 months prior to Screening.
- Current active and symptomatic COVID-19 infection.
- 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.
- History of hypersensitivity to any ingredient of any therapeutic monoclonal antibody.
- Have an active infection.
- Part 2: Use of burosumab following completion of Part 1 of the study.
- History of donation of blood within 60 days prior to Screening.
- Part 2: Use of any therapeutic mAb other than KK8123 within 90 days prior to Week 0 of Part 2.
- Uncontrolled diabetes mellitus at Screening.
- History of known immunodeficiency.
- History of alcoholism or drug abuse.
- Part 2: have an active infection.
- Part 2: Donation of blood within 60 days prior to Week 0 of Part 2.
- Participants who are lactating.
- Part 2: Participants who are lactating.
- Serum iPTH ≥ 2.5 × ULN at Screening.
- Part 2: 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.
- Part 2: Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Week 0 of Part 2.
- Part 2: Use of oral bisphosphonates following completion of Part 1 of the study.
- Use of any IP or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Part 2: Use of teriparatide or abaloparatide in the 2 months prior to Week 0 of Part 2.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.