NCT07404111

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_1

Timeline
35mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
May 2026Aug 2029

First Submitted

Initial submission to the registry

October 24, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

2.3 years

First QC Date

October 24, 2025

Last Update Submit

August 25, 2026

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

    52 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

    36 Weeks

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

    36 Weeks

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

    36 Weeks

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

    36 Weeks

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

    36 Weeks

  • +3 more secondary outcomes

Study Arms (8)

Part 1 Cohort 1, dose #1

EXPERIMENTAL

A single 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, dose #2

EXPERIMENTAL

A single 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, dose #3

EXPERIMENTAL

A single 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 4, dose #4

EXPERIMENTAL

A single 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 5, dose #5

EXPERIMENTAL

A single 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 6, Part 2 dose

EXPERIMENTAL

A single dose of VV-14305 determined from Cohorts 1 to 5 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 to 5 will be administered. In addition, prednisone will be administered prior to and after VV-14305.

Genetic: VV-14305

Part 2 Sham Arm

EXPERIMENTAL

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-14305GENETIC

VV-14305 will be administered via peribulbar injection.

Part 1 Cohort 1, dose #1Part 1 Cohort 2, dose #2Part 1 Cohort 3, dose #3Part 1 Cohort 4, dose #4Part 1 Cohort 5, dose #5Part 1 Optional Cohort 6, Part 2 dosePart 2 Treatment Arm
Sham (No Treatment)OTHER

Sham solution such as Saline

Part 2 Sham Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 to 80 years of age (inclusive) at Screening.
  • 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 10 Days prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), antiplatelet/anticoagulant medications or any herbal supplements, vitamins, or multivitamins with antiplatelet/anticoagulant properties. Product use may resume following the administration of VV-14305 or sham.
  • 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 chronic 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 investigational drug, biologic or device clinical trials within 30 days prior to Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kriya Clinical Trial Site

Livonia, Michigan, 48152, United States

RECRUITING

Kriya Clinical Trial Site

Las Vegas, Nevada, 89144, United States

RECRUITING

Kriya Clinical Trial Site

Erie, Pennsylvania, 16505, United States

RECRUITING

Kriya Clinical Trial Site

Auckland, New Zealand

RECRUITING

Kriya Clinical Trial Site

Wellington, New Zealand

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Central Study Contacts

VP, Medical Affairs

CONTACT

984-884-5058clinicaltrials@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

May 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

NZ(2)US(3)