A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topic… (NCT06978244) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers
United States24 participantsStarted 2025-07-29
Plain-language 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)
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Incidence of DLTs (dose-limiting toxicities)
Timeframe: Approximately 6 months
2
Incidence of treatment-emergent AEs (TEAEs)
Timeframe: Approximately 6 months
3
Treatment-emergent changes in systemic and ocular safety assessments
Timeframe: Approximately 6 months
4
PK profiles and following parameter, where data allow (Cmax)
Timeframe: Approximately 6 months
5
PK profiles and following parameter, where data allow ( Tmax)
Timeframe: Approximately 6 months
6
PK profiles and following parameter, where data allow (Ctau)
Timeframe: Approximately 6 months
7
PK profiles and following parameter, where data allow (Tlast)
Timeframe: Approximately 6 months
8
PK profiles and following parameter, where data allow ( AUClast)
✕. 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
9
PK profiles and following parameter, where data allow (AUCtau)
Timeframe: Approximately 6 months
10
PK profiles and following parameter, where data allow (AUCinf)
Timeframe: Approximately 6 months
11
PK profiles and following parameter, where data allow (ke1)
Timeframe: Approximately 6 months
12
PK profiles and following parameter, where data allow (t1/2)