CompletedPhase 1

Study of the Safety of USB005 in Healthy Volunteers

United States32 participantsStarted 2018-07-25

Plain-language summary

This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.

Age range18 Years – 64 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.

✓. Healthy male or female volunteers, aged 18-64 years (inclusive) at the time of signing the ICF;
✓. For females:
✓. Surgically sterilized (eg, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening and menopause will be confirmed by a plasma FSH level of \>40 IU/L) or
✓. Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and
✓. Women with a negative pregnancy test (β-hCG assay) at screening and Day -1;
✓. Weight of 45-100 kg and BMI of 17.5-35 kg/m2 (inclusive);
✓. Blood pressure no greater than 120/80 mm Hg (inclusive);
✓. Healthy, as determined by medical history, physical examination, vital signs, and clinical laboratory tests, unless the Investigator considers an abnormality to be clinically irrelevant;

✕. Any history of severe ocular trauma in either eye at any time;
✕. Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
✕. Any condition preventing reliable ocular assessment (eg, applanation tonometry, fundus examination) in either eye;
✕. Intended use of contact lenses during this study or 1 week before Day -1;
✕. Current or chronic history of ocular disease within the past 3 months of screening visit in either eye;
✕. Current or chronic history of ocular infection (bacterial, viral or fungal) or corneal irritation within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation (ie, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
✕. Abnormal tearing, OR expected regular use of prescription or expected use of OTC tear substitutes within 4 weeks prior to Day -1, and for the duration of the study;
✕. Previous or expected use of ocular (topical, periocular, intravitreal), local (inhaled or nasal), or systemic steroid or glucocorticoid medications within 4 weeks prior to Day -1, and for the duration of the study;

Percentage of volunteers with dose limiting toxicities in each cohort

Timeframe: 36 days

Percentage of volunteers in each cohort with ocular adverse events

Timeframe: 36 days

Percentage of volunteers in each cohort with systemic adverse events

Timeframe: 36 days

Percentage of volunteers with clinically significant out of range laboratory values

Timeframe: 36 days

NCT IDNCT03615196

SponsorUS Biotest, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-08

Who can participate

Age range18 Years – 64 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.

✓. Healthy male or female volunteers, aged 18-64 years (inclusive) at the time of signing the ICF;
✓. For females:
✓. Surgically sterilized (eg, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening and menopause will be confirmed by a plasma FSH level of \>40 IU/L) or
✓. Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and
✓. Women with a negative pregnancy test (β-hCG assay) at screening and Day -1;
✓. Weight of 45-100 kg and BMI of 17.5-35 kg/m2 (inclusive);
✓. Blood pressure no greater than 120/80 mm Hg (inclusive);
✓. Healthy, as determined by medical history, physical examination, vital signs, and clinical laboratory tests, unless the Investigator considers an abnormality to be clinically irrelevant;

✕. Any history of severe ocular trauma in either eye at any time;
✕. Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
✕. Any condition preventing reliable ocular assessment (eg, applanation tonometry, fundus examination) in either eye;
✕. Intended use of contact lenses during this study or 1 week before Day -1;
✕. Current or chronic history of ocular disease within the past 3 months of screening visit in either eye;
✕. Current or chronic history of ocular infection (bacterial, viral or fungal) or corneal irritation within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation (ie, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
✕. Abnormal tearing, OR expected regular use of prescription or expected use of OTC tear substitutes within 4 weeks prior to Day -1, and for the duration of the study;
✕. Previous or expected use of ocular (topical, periocular, intravitreal), local (inhaled or nasal), or systemic steroid or glucocorticoid medications within 4 weeks prior to Day -1, and for the duration of the study;

What they're measuring

Percentage of volunteers with dose limiting toxicities in each cohort

Timeframe: 36 days

Percentage of volunteers in each cohort with ocular adverse events

Timeframe: 36 days

Percentage of volunteers in each cohort with systemic adverse events

Timeframe: 36 days

Percentage of volunteers with clinically significant out of range laboratory values

Timeframe: 36 days