Active — Not RecruitingPhase 1

A Study of the Safety, Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis

China16 participantsStarted 2023-09-04

Plain-language summary

This Phase I study is intended to evaluate the safety, tolerability, PK/PD profiles and preliminary efficacy via corneal intrastromal administration in patients with herpes simplex virus-1 stromal keratitis (HSK), with a dose exploration of four ascending doses of BD111 (investigative drug product).

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 to 70 years old;
✓. Clinically diagnosed patients with recurrent herpes simplex virus type I stromal keratitis (HSK). Definition of recurrence: the patient had been diagnosed with HSK and received "local antiviral eye drugs and oral antiviral drugs + local glucocorticoid eye drops" for 3 weeks with successful clinical efficacy. Before enrollment, the clinical recurrence of HSK occurred again with symptoms including tearing, photophobia, pain, blurred vision and foreign body sensation, and signs as recurrence of active inflammatory lesions examined by slit lamp;
✓. HSV-1 nucleic acid test (qPCR method) positive;
✓. No use of other systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
✓. No systemic immune diseases;
✓. Good eyelid structure and blinking function;
✓. Eye structure and function assessment showing potential for visual recovery;
✓. No retinal detachment;

Exclusion criteria

✕. Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to infectious conjunctivitis, keratitis, scleritis, and endophthalmitis;
✕. Patients with bilateral viral keratitis
✕. Previous corneal transplant surgery in the study eye;

What they're measuring

Dose-limiting toxicity (DLT)

Timeframe: 12 months

Maximum tolerated dose (MTD)

Timeframe: 12 months

Recommended Phase 2 dose (RP2D)

Timeframe: 12 months

Incidence and characteristics of adverse events (AE) and serious adverse events (SAE) during the study

Timeframe: 12 months

Trial details

NCT IDNCT06474416

SponsorShanghai BDgene Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10

View on ClinicalTrials.gov More Herpes Simplex Virus Type I Stromal Keratitis trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 to 70 years old;
✓. Clinically diagnosed patients with recurrent herpes simplex virus type I stromal keratitis (HSK). Definition of recurrence: the patient had been diagnosed with HSK and received "local antiviral eye drugs and oral antiviral drugs + local glucocorticoid eye drops" for 3 weeks with successful clinical efficacy. Before enrollment, the clinical recurrence of HSK occurred again with symptoms including tearing, photophobia, pain, blurred vision and foreign body sensation, and signs as recurrence of active inflammatory lesions examined by slit lamp;
✓. HSV-1 nucleic acid test (qPCR method) positive;
✓. No use of other systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
✓. No systemic immune diseases;
✓. Good eyelid structure and blinking function;
✓. Eye structure and function assessment showing potential for visual recovery;
✓. No retinal detachment;

Exclusion criteria

✕. Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to infectious conjunctivitis, keratitis, scleritis, and endophthalmitis;
✕. Patients with bilateral viral keratitis
✕. Previous corneal transplant surgery in the study eye;