GBP-213 in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT07891364 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HJG-XJ-GBP213-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GBP-213 in patients with autosomal dominant polycystic kidney disease (ADPKD).

Conditions

Autosomal Dominant Polycystic Kidney

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of GBP-213 in patients with rapidly progressive ADPKD

  The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their relationship to the investigational drug

  From first treatment (Week 1, Day 1) to 12 months after the last dose (Week 13, Day 1)

Secondary Outcomes (7)

• Area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t)

  From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

• Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞)

  From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

• Maximum plasma concentration (Cmax)

  From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

• Time to maximum plasma concentration (Tmax)

  From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

• Terminal elimination half-life (t1/2z)

  From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

Study Arms (4)

GBP-213 Dose Escalation dose 1

EXPERIMENTAL

GBP-213 subcutaneous injection

Drug: GBP-213

GBP-213 Dose Expansion dose 2

EXPERIMENTAL

GBP-213 subcutaneous injection

Drug: GBP-213

GBP-213 Dose Escalation dose 3

EXPERIMENTAL

GBP-213 subcutaneous injection

Drug: GBP-213

GBP-213 Dose Escalation dose 4

EXPERIMENTAL

GBP-213 subcutaneous injection

Drug: GBP-213

Interventions

GBP-213 DRUG

Subcutaneous injection

GBP-213 Dose Escalation dose 1; GBP-213 Dose Escalation dose 3; GBP-213 Dose Escalation dose 4; GBP-213 Dose Expansion dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years inclusive at the time of signing the ICF, regardless of sex.
• Clinically diagnosed with ADPKD
• Meets criteria for rapidly progressive ADPKD.
• ≥eGFR≥30mL/min/1.73m²
• Understands the study procedures and voluntarily signs the written informed consent form.

You may not qualify if:

• Diagnosis of renal cystic disease due to other causes, such as autosomal recessive polycystic kidney disease, tuberous sclerosis complex, medullary cystic kidney disease, simple renal cysts, acquired cystic kidney disease, etc.
• Other severe or chronic hepatic or renal diseases in addition to ADPKD, such as glomerular or tubulointerstitial disease, end-stage renal disease, viral/alcoholic hepatitis, active autoimmune hepatitis, liver cancer, renal cancer, acute kidney injury, cirrhosis, etc.
• Use of a vasopressin V2 receptor antagonist (e.g., tolvaptan), somatostatin analog (e.g., lanreotide, pasireotide, octreotide), mTOR inhibitor (e.g., everolimus, sirolimus), or any investigational drug within 30 days or 5 half-lives before dosing, whichever is longer.
• Any of the following cardiovascular or cerebrovascular events within 6 months before dosing: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class III or IV heart failure, stroke, etc.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Leyi Gu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyi Gu

CONTACT

86-21-58752345; guleyi@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)