A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers

NCT06978244 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BL-RX01-BL1332-1101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

Conditions

Ocular Pain

Outcome Measures

Primary Outcomes (12)

• Incidence of DLTs (dose-limiting toxicities)

  To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

  Approximately 6 months

• Incidence of treatment-emergent AEs (TEAEs)

  To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

  Approximately 6 months

• Treatment-emergent changes in systemic and ocular safety assessments

  To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

  Approximately 6 months

• PK profiles and following parameter, where data allow (Cmax)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow ( Tmax)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (Ctau)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (Tlast)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow ( AUClast)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (AUCtau)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (AUCinf)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (ke1)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

• PK profiles and following parameter, where data allow (t1/2)

  To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

  Approximately 6 months

Study Arms (2)

BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations)

EXPERIMENTAL

BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops

Drug: BL1332 ophthalmic solution

BL1332 vehicle

PLACEBO COMPARATOR

BL1332 vehicle administered as topical ocular drops

Drug: BL1332 ophthalmic vehicle

Interventions

BL1332 ophthalmic solution DRUG

Both arms taken four times a day for 1 day

BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations)

BL1332 ophthalmic vehicle DRUG

Both arms taken four times a day for 1 day

BL1332 vehicle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent prior to conduct of any study-related assessment
• Male and female subjects ≥18 to ≤50 years of age and in good health, as assessed by the Investigator from past medical history, physical examination, and laboratory tests at Screening
• Vital signs assessed in the sitting position after the subject has rested for at least 3 minutes, within the following ranges at Screening and at the Baseline Visit:
• Oral body temperature ≥35.0°C and ≤37.5°C
• Systolic blood pressure ≥90 and \<140 mmHg
• Diastolic blood pressure ≥50 and \<90 mmHg
• Pulse rate ≥40 and ≤100 bpm
• Body weight ≥50 kg
• Body mass index (BMI) between 18.0 and 30.0 kg/m2 \[BMI = Body weight (kg) / Height (m)2\]
• Corrected visual acuity of 20/40 (Snellen) or better in each eye at Screening
• Able to communicate well with the Investigator and to understand and comply with the requirements of the study

You may not qualify if:

• Women of childbearing potential (WOCBP) or non-vasectomized males with partners of childbearing potential are not eligible, unless they are using an effective method of contraception and agree to use an effective method of contraception until at least 30 days after study treatment.
• Women are considered of childbearing potential unless they have undergone permanent sterilization (such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) or have been amenorrheic for ≥12 months without an alternative medical cause.
• Effective methods of contraception include systemic hormonal (inhibition of ovulation not primary mode of action) containing progestins only; single barrier male or female condom with or without spermicide or cap; diaphragm; sponge with spermicide; double barrier (male condom combined with one of the barrier methods); or intrauterine device
• Women who are pregnant, lactating, or breastfeeding are excluded.
• Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator and based on the content of the Investigator's Brochure (IB), preclude the safe administration of IP or safe participation in this study
• Use of gabapentinoids or opioids within 30 days prior to Screening
• Use of topical capsaicin within 30 days prior to Screening
• Chronic use (defined as ≥15 days/month for 3 months prior to Screening) of acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) or anticipated regular (daily) use during the study
• Chronic use of medications or dietary supplements (over-the-counter and/or prescription) that have not been stable for ≥14 days prior to Screening or any anticipated change in the chronic medication regimen
• Reported use of tobacco products within 3 months prior to Screening and/or urine cotinine level consistent with use of tobacco product (not passive exposure) at Screening
• History of use of marijuana/cannabinoid (CBD) or illicit substances including cocaine, heroin, methamphetamine, hallucinogens, or non-prescribed opioids within 3 months prior to Screening
• Use of systemic corticosteroids, anticoagulants, or migraine medications such as ergotamine, calcitonin gene-related peptide (CGRP) antagonists within 30 days prior to the Baseline Visit
• Use of cytochrome P450 3A4 (CYP3A4) or CYP3A5 inhibitors or inducers within 2 weeks prior to the Baseline Visit
• History of any ocular surgery or ocular laser intervention within 6 months prior to Screening
• History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia. Subjects with a history of acute eye disease (such as infection, corneal abrasion, or allergy) within 6 months prior to Screening may be eligible if the disease is not currently active.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Site 101

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Design

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

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)