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

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NCT06525636 · readout in 541 d

Sponsored by Kyowa Kirin Co., Ltd. (industry) · 4151.T — their whole pipeline →. With Kyowa Kirin, Inc..

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

24estimated

Sites

Countries

France, Germany, Spain +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-10-09

actual

When the study began enrolling

Primary completion

2028-02-11

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-05-10

estimated

The whole study's end, after follow-up

First posted

2024-07-29

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-11-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

X-linked Hypophosphatemia

Intervention

Drug: KK8123

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Number of participants with TEAEs

measured For up to 44 weeks.

Part 1: Percentage of participants with TEAEs

measured For up to 44 weeks.

Part 2: Number of participants with TEAEs

measured For up to 52 weeks.

Part 2: Percentage of participants with TEAEs

measured For up to 52 weeks.

Part 1: Change from baseline for haematology laboratories values

measured For up to 44 weeks.

Part 2: Change from baseline for haematology laboratories values

measured For up to 52 weeks.

Part 1: Change from baseline for clinical chemistry laboratories values

measured For up to 44 weeks.

Part 2: Change from baseline for clinical chemistry laboratories values

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for FSH

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for FSH

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for estradiol

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for estradiol

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for temperature

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for temperature

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for QT

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for QT

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for QTc

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for QTc

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for QTCF

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for QTCF

measured For up to 52 weeks.

Part 1: Change from baseline in continuous variables for QRS

measured For up to 44 weeks.

Part 2: Change from baseline in continuous variables for QRS

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks..

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

Part 1: KK8123 concentrations by time to steady state

measured For up to 44 weeks.

Part 2: KK8123 concentrations by time to steady state

measured For up to 52 weeks.

Part 1: KK8123 concentrations by accumulation ratio

measured For up to 44 weeks.

Part 2: KK8123 concentrations by accumulation ratio

measured For up to 52 weeks.

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

measured For up to 44 weeks.

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

measured For up to 52 weeks.

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