A Study of VV-14305 for the Treatment of Thyroid Eye Disease

NCT07404111 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KRIYA-586-101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).

Conditions

Thyroid Eye Disease (TED)

Outcome Measures

Primary Outcomes (3)

• Part 1: Safety and Tolerability of VV-14305 in participants with TED

  Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations

  52 Weeks

• Part 2: Safety of VV-14305 in Participants with TED Compared to Sham

  Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations

  36 Weeks

• Part 2: Efficacy of VV-14305 in participants with TED compared to Sham

  Percentage of participants with reduction in proptosis in the study eye as measured by exophthalmometer

  36 Weeks

Secondary Outcomes (8)

• Part 1: Efficacy associated with VV-14305 in participants with TED

  52 Weeks

• Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)

  52 Weeks

• Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)

  52 Weeks

• Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)

  52 Weeks

• Efficacy associated with VV-14305 in participants with TED (as compared to Sham for Part 2)

  52 Weeks

Study Arms (6)

Part 1 Cohort 1, low dose

EXPERIMENTAL

A single low dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 1 Cohort 2, mid dose

EXPERIMENTAL

A single mid dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 1 Cohort 3, high dose

EXPERIMENTAL

A single high dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 1 Optional Cohort 4, Part 2 dose

EXPERIMENTAL

A single dose of VV-14305 determined from Cohorts 1, 2, and 3 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 2 Treatment Arm

EXPERIMENTAL

A single dose of VV-14305 determined from Cohorts 1, 2, and 3 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 2 Sham Arm

SHAM COMPARATOR

A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection.

Other: Sham (No Treatment)

Interventions

VV-14305 GENETIC

VV-14305 will be administered via peribulbar injection.

Part 1 Cohort 1, low dose; Part 1 Cohort 2, mid dose; Part 1 Cohort 3, high dose; Part 1 Optional Cohort 4, Part 2 dose; Part 2 Treatment Arm

Sham (No Treatment) OTHER

Sham solution such as Saline

Part 2 Sham Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 to 80 years of age (inclusive) at Screening.
• Body Mass Index (BMI) of 19 to 34 kg/m2 (inclusive).
• Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).
• Best Corrected Visual Acuity (BCVA) score of 20/60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.
• Must be willing and able to cease product use prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), medications or any herbal supplements, vitamins, or multivitamins with antiplatelet/anticoagulant properties.
• The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.
• Participants must be diagnosed with TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.

You may not qualify if:

• History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD; Other orbital or ophthalmic diseases, including inflammatory conditions, optic neuropathy, tumors, glaucoma with visual field defect or visual field loss, that in the opinion of the Investigator and/or Medical Monitor is clinically significant.
• Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.
• Diagnosed with diabetes (HbA1c ≥6.5%).
• History of malignancy requiring chemotherapy and/or radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.
• Known allergy or condition that would contraindicate the use of required study medications.
• Any Screening assessment or laboratory value that, in the opinion of the Investigator and/or Medical Monitor, is clinically significant and renders the subject not suitable for study participation.
• Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.
• Participant requires or, in the opinion of the Investigator, is likely to require immediate surgical ophthalmological/orbital intervention or irradiation of either eye; Has had any prior surgery for TED including orbital decompression, strabismus surgery and any eyelid surgery on either eye.
• Prior participation in other gene therapy, investigational drug, biologic or device clinical trials within 30 days prior to Screening.

Sponsors & Collaborators

• Kriya Therapeutics, Inc.: lead

Study Sites (1)

Kriya Clinical Trial Site

Auckland, New Zealand, New Zealand

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

VP, Medical Affairs

CONTACT

984.884.5058; clinicaltrials@kriyatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)