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

Bausch + Lomb

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Ocular Pain

Treatments: Drug: BL1332 ophthalmic vehicle; Drug: BL1332 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06978244

BL-RX01-BL1332-1101

Details and patient eligibility

About

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)

Full 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)

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: BL1332 ophthalmic solution

BL1332 vehicle

Placebo Comparator group

Description:

BL1332 vehicle administered as topical ocular drops

Treatment:

Drug: BL1332 ophthalmic vehicle