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Part I: Cohort 3 for Hypophosphatemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Kyowa Kirin, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
2. Diagnosed with XLH (as documented by the investigator).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for up to 52 weeks.
Awards & highlights

Summary

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

Eligible Conditions
  • Hypophosphatemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for up to 52 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and for up to 52 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Before and after administration presented at each time point in categorical variables for renal ultrasound
Part 1: Change from baseline for clinical chemistry laboratories values
Part 1: Change from baseline for haematology laboratories values
+57 more
Secondary study objectives
Part 1: ADA positivity titers to be assessed by absolute number
Part 1: ADA positivity titers to be assessed by percentage
Part 2: ADA positivity titers to be assessed by absolute number
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part I: Cohort 4Experimental Treatment1 Intervention
Optional, multiple doses of KK8123
Group II: Part I: Cohort 3Experimental Treatment1 Intervention
High dose, multiple doses of KK8123
Group III: Part I: Cohort 2Experimental Treatment1 Intervention
Mild dose, multiple doses of KK8123
Group IV: Part I: Cohort 1Experimental Treatment1 Intervention
Low Dose, single dose of KK8123
Group V: Part 2: Extension PeriodExperimental Treatment1 Intervention
High dose, multiple doses as confirmed for Cohort 3 of KK8123.

Find a Location

Who is running the clinical trial?

Kyowa Kirin, Inc.Lead Sponsor
48 Previous Clinical Trials
5,721 Total Patients Enrolled
8 Trials studying Hypophosphatemia
390 Patients Enrolled for Hypophosphatemia
Kyowa KirinStudy ChairKyowa Kirin, Inc.
~16 spots leftby Feb 2028
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