A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
NCT06525636 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-11-14
Summary
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
Conditions
- X-linked Hypophosphatemia
Interventions
- DRUG
-
KK8123
Subcutaneous administration
Sponsors & Collaborators
-
Kyowa Kirin, Inc.
collaborator INDUSTRY -
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kyowa Kirin · Kyowa Kirin, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-09
- Primary Completion
- 2028-02-11
- Completion
- 2028-05-10
- FDA Drug
- Yes
Countries
- United States
- France
- Germany
- Spain
Study Locations
More Related Trials
-
Open-Label Extension Study to Assess GLM101 in PMM2-CDG Patients
NCT06657859 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
NCT01560286 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB)
NCT07185256 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)
NCT05200104 ·Status: WITHDRAWN ·Phase: PHASE2
-
Effective Dosing of Burosumab in XLH
NCT07183579 ·Status: RECRUITING
-
Safety and Efficacy of HMI-103 in Participants With Classical PKU Due to PAH Deficiency
NCT05222178 ·Status: TERMINATED ·Phase: PHASE1
-
24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG
NCT05549219 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
NCT04706013 ·Status: RECRUITING ·Phase: PHASE3
-
First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
NCT02675465 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
AAV2/8-LSPhGAA (ACTUS-101) in Late-Onset Pompe Disease
NCT03533673 ·Status: COMPLETED ·Phase: PHASE1
-
An Initial Study of AZD7325 in Adults With Fragile X Syndrome
NCT03140813 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)
NCT01212744 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency
NCT00157118 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation
NCT06789913 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU
NCT03694353 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria
NCT05270837 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
NCT03231878 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU.
NCT05827536 ·Status: TERMINATED ·Phase: NA
-
Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
NCT07060300 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)
NCT00924703 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
NCT04159103 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of BH4, a New and Simple Treatment of Mild PKU
NCT00260000 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 in Mucopolysaccharidosis III, Type B (MPS IIIB)
NCT02324049 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU
NCT01889862 ·Status: COMPLETED ·Phase: PHASE3
-
Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase
NCT03856203 ·Status: COMPLETED