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KK8123 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
Male or female patients aged 18 to 65 years diagnosed with XLH, with specific laboratory values at Screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new drug called KK8123 in adults with a condition called X-linked hypophosphatemia.

Who is the study for?
Adults aged 18 to 65 with X-linked hypophosphatemia (XLH) can join this trial. They must be on a stable pain medication routine, agree not to change their diet or exercise during the study, and use effective contraception. Pregnant women can't participate, nor those who've had certain treatments for XLH or have medical conditions that might interfere with the study.
What is being tested?
The trial is testing KK8123, a new potential treatment for adults with XLH. This first-in-human study aims to evaluate its safety and how well it works in managing low phosphate levels associated with the condition.
What are the potential side effects?
Since KK8123 is being tested for the first time in humans, side effects are currently unknown but will be closely monitored throughout the trial. Participants may experience unexpected reactions due to the novelty of this treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old and have been diagnosed with XLH.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

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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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