Clinical trial NCT06978244: A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers
Official title: A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Ocular Pain
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

1. Written informed consent prior to conduct of any study-related assessment
2. 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
3. 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
4. Body weight ≥50 kg
5. Body mass index (BMI) between 18.0 and 30.0 kg/m2 \[BMI = Body weight (kg) / Height (m)2\]
6. Corrected visual acuity of 20/40 (Snellen) or better in each eye at Screening
7. Able to communicate well with the Investigator and to understand and comply with the requirements of the study

Exclusion Criteria:

1. 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.

   1. 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.
   2. 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
   3. Women who are pregnant, lactating, or breastfeeding are excluded.
2. 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
3. Use of gabapentinoids or opioids within 30 days prior to Screening
4. Use of topical capsaicin within 30 days prior to Screening
5. 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
6. 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
7. 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
8. 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
9. 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
10. Use of cytochrome P450 3A4 (CYP3A4) or CYP3A5 inhibitors or inducers within 2 weeks prior to the Baseline Visit
11. History of any ocular surgery or ocular laser intervention within 6 months prior to Screening
12. 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.
13. Any currently active ocular condition that requires use of topical eye drops
14. Contact lens use within 2 weeks prior to Screening and throughout the study
15. Consumption of alcohol within 48 hours prior to the Baseline Visit and throughout the study
16. Donation or loss of ≥450 mL of blood within 8 weeks prior to Screening or longer, if required by local regulation
17. Hemoglobin \<11.0 g/dL at Screening
18. Current or past history of human immunodeficiency virus (HIV) disease and/or hepatitis
19. Past participation in a clinical study within 30 days prior to Screening

Primary outcomes:
measure: Incidence of DLTs (dose-limiting toxicities)
timeFrame: Approximately 6 months
measure: Incidence of treatment-emergent AEs (TEAEs)
timeFrame: Approximately 6 months
measure: Treatment-emergent changes in systemic and ocular safety assessments
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (Cmax)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow ( Tmax)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (Ctau)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (Tlast)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow ( AUClast)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (AUCtau)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (AUCinf)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (ke1)
timeFrame: Approximately 6 months
measure: PK profiles and following parameter, where data allow (t1/2)
timeFrame: Approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: Site 101
state: New Jersey
Study officials:
References: