Health TrialsbyHealthPanel

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

ConditionX-linked Hypophosphatemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKyowa Kirin Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.

Body weight is at least 40 kg.

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.

Disqualifiers

For XLH participants previously treated with the applicable prior therapy, use within the protocol defined washout period prior to ICF signature.

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 hypersensitivity to any ingredient of any therapeutic monoclonal antibody.

Have an active infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KK8123

    Drug

    Subcutaneous administration

Treatment groups

39 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part 1: Cohort 1Experimental treatment 1 intervention
Group B: Part 1: Cohort 2Experimental treatment 1 intervention
Group C: Part 1: Cohort 3Experimental treatment 1 intervention
Group D: Part 1: Cohort 4AExperimental treatment 1 intervention
Group E: Part 1: Cohort 4BExperimental treatment 1 intervention
Group F: Part 2: Extension PhaseExperimental treatment 1 intervention

Trial outcomes

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyowa Kirin Co., Ltd.

Lead sponsor

Kyowa Kirin, Inc.

Collaborator

Source ClinicalTrials.gov
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