Healthy VolunteersPhase 1NCT03615196
Study of the Safety of USB005 in Healthy Volunteers
A Phase 1 study testing USB005 (aclerastide) Ophthalmic Solution in people with Healthy Volunteers, run by US Biotest, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- USB005 (aclerastide) Ophthalmic Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2018to 2 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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;
- IOP measurement oculus uterque (OU, both eyes) <21 mm Hg at screening and Day -1;
- BCVA 20/30 or better (LogMAR and Snellen Equivalent) at both the screening visit and Day -1 in at least 1 eye;
- Normal vision as determined by comprehensive ocular examination;
- Able and willing to provide signed, written, informed consent;
- Willing to communicate with the Investigator and site staff and comply with all study procedures and requirements;
- Willing and able to be confined to the clinical study site as required by the protocol.
Who cannot join
- 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;
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- 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;
- At the ophthalmic investigator's discretion, any volunteers who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results;
- Use of any non-diagnostic topical ophthalmic solutions through the duration of the study;
- Clinically significant metabolic disease such as diabetes, asthma, or hypertension (ie, blood pressure >120/80 mm Hg on two successive visits during screening);
- Taken any nicotine-containing products in the last 6 months prior to dosing or for the duration of the study;
- At the Investigator's discretion, any volunteers with a history or presence of clinically significant cardiovascular disorders, including a history of orthostatic hypotension, arrhythmia and syncope (including vasovagal syncope), or respiratory, metabolic, renal, hepatic, immunologic, endocrine, dermatologic, venereal, hematologic, neurologic, psychiatric (eg, major depression with suicidal ideation, or suicide attempt), malignant neoplasm, musculoskeletal, connective tissue, urinary disease or disorders;
- History of clinically significant drug or food allergy;
- Positive HIV, hepatitis B or C viral test at screening;
- Taken any prescription drugs within 14 days or within 5 half-lives, whichever is longer, prior to dosing;
- Taken any non-prescription or OTC drugs including vitamins or herbal medications within 14 days or within 5 half-lives whichever is longer, prior to dosing;
- History or presence, as judged by the Investigator, of drug or alcohol abuse (ie, alcohol consumption >2 drinks/day over the last 3 months prior to screening); drug abuse is any use of illegal drugs or prescription-drug over usage or addiction. A positive drug screen or alcohol screen will disqualify a volunteer from study participation;
- Donated >400 mL and/or received any blood or blood products within the previous 3 months prior to screening;
- Taken any investigational medication and/or participated in any clinical studies within 30 days of screening;
- Any volunteer who, in the judgment of the Investigator, may not be able to cooperate fully with the study staff, may have difficulty following some study requirements, or is otherwise not qualified for the study;
- Any volunteer who is directly involved in the conduct of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of USB005 in a Phase 1 Normal, Healthy Volunteer Ocular Safety and PK Study
This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.
Read the detailed description
This is a Phase 1, single-center, randomized, double-masked, placebo-controlled, multiple ascending dose study in healthy volunteers. Thirty-two male and female volunteer subjects, between the ages of 18 and 64 years of age, will be enrolled. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to USB005 or placebo in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration. The four cohorts will be identified as: Cohort 1(0.03% USB005 or placebo), Cohort 2 (0.1% USB005 or placebo), Cohort 3 (0.3% USB005 or placebo), and Cohort 4 (0.45% USB005 or placebo). Volunteers in the four cohorts will self-administer a single drop of USB005 or placebo into the study eye, three times a day for 28 days. The study eye in which the drug is applied to will be determined based on screening assessments. Subjects will be followed for 8 days after the last USB005 or placebo administration.
The safety and tolerability of USB005 will be demonstrated by local toxicity, adverse events, laboratory assessments, vital signs, and a comprehensive eye exam. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of USB005. Dropouts will be replaced after consultation with the Sponsor.
- Conditions
- Healthy Volunteers
- Being tested
- USB005 (aclerastide) Ophthalmic Solution, USB005 Ophthalmic Solution Placebo
- Keywords
- NorLeu3-A(1-7), USB005, aclerastide, corneal repair, corneal injury
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USB005 (aclerastide) Ophthalmic SolutionDrug
Aclerastide ([Nle3]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP.
USB005 Ophthalmic Solution PlaceboDrug
A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.
| Study group | Role | What they receive |
|---|---|---|
| USB005 0.03% | Experimental | USB005 (aclerastide) Ophthalmic Solution 0.03%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) Receives: Drug: USB005 (aclerastide) Ophthalmic Solution |
| USB005 0.1% | Experimental | USB005 (aclerastide) Ophthalmic Solution 0.1%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) Receives: Drug: USB005 (aclerastide) Ophthalmic Solution |
| USB005 0.3% | Experimental | USB005 (aclerastide) Ophthalmic Solution 0.3%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) Receives: Drug: USB005 (aclerastide) Ophthalmic Solution |
| USB005 0.45% | Experimental | USB005 (aclerastide) Ophthalmic Solution 0.45%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) Receives: Drug: USB005 (aclerastide) Ophthalmic Solution |
| USB005 Placebo | Placebo comparator | USB005 Ophthalmic Solution Placebo; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) Receives: Drug: USB005 Ophthalmic Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of volunteers with dose limiting toxicities in each cohort
Measured: 36 days
Percentage of volunteers in each cohort with ocular adverse events
Measured: 36 days
Percentage of volunteers in each cohort with systemic adverse events
Measured: 36 days
Percentage of volunteers with clinically significant out of range laboratory values
Measured: 36 days
Secondary outcomes (6)
Maximum observed concentrations (Cmax)
Measured: 36 days
Time to reach maximum observed plasma concentration (Tmax) after multiple ascending dose
Measured: 36 days
Apparent terminal half-life (T1/2) after multiple ascending dose
Measured: 36 days
Area under the plasma concentration versus time curve from time 0 to infinity (AUCinf)
Measured: 36 days
Area under the plasma concentration versus time curve up to the last measurable concentration (AUC0-last)
Measured: 36 days
Apparent clearance (CL/F)
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Jul 2018
- Primary completion8 Nov 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Biotest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Michael Sheety, MD, Principal investigator, WCCT Global, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615196
- Sponsor's protocol ID
- USB005-2017-01
- Status last verified
- Apr 2019
- First submitted
- 30 Jul 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdallah WF, Louie SG, Zhang Y, Rodgers KE, Sivok E, S diZerega G, Humayun MS. NorLeu3A(1-7) Accelerates Clear Corneal Full Thickness Wound Healing. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):2187-94. doi: 10.1167/iovs.15-18515.
PubMed 27116546
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of USB005 in a Phase 1 Normal, Healthy Volunteer Ocular Safety and PK Study
- ClinicalTrials.gov ID
- NCT03615196
- Acronym / sponsor ID
- USB005-2017-01
- Conditions
- Healthy Volunteers
- Keywords
- NorLeu3-A(1-7), USB005, aclerastide, corneal repair, corneal injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- US Biotest, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.
Detailed description
This is a Phase 1, single-center, randomized, double-masked, placebo-controlled, multiple ascending dose study in healthy volunteers. Thirty-two male and female volunteer subjects, between the ages of 18 and 64 years of age, will be enrolled. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to USB005 or placebo in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration. The four cohorts will be identified as: Cohort 1(0.03% USB005 or placebo), Cohort 2 (0.1% USB005 or placebo), Cohort 3 (0.3% USB005 or placebo), and Cohort 4 (0.45% USB005 or placebo). Volunteers in the four cohorts will self-administer a single drop of USB005 or placebo into the study eye, three times a day for 28 days. The study eye in which the drug is applied to will be determined based on screening assessments. Subjects will be followed for 8 days after the last USB005 or placebo administration.
The safety and tolerability of USB005 will be demonstrated by local toxicity, adverse events, laboratory assessments, vital signs, and a comprehensive eye exam. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of USB005. Dropouts will be replaced after consultation with the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| USB005 0.03% | Experimental | Drug: USB005 (aclerastide) Ophthalmic SolutionUSB005 (aclerastide) Ophthalmic Solution 0.03%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) |
| USB005 0.1% | Experimental | Drug: USB005 (aclerastide) Ophthalmic SolutionUSB005 (aclerastide) Ophthalmic Solution 0.1%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) |
| USB005 0.3% | Experimental | Drug: USB005 (aclerastide) Ophthalmic SolutionUSB005 (aclerastide) Ophthalmic Solution 0.3%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) |
| USB005 0.45% | Experimental | Drug: USB005 (aclerastide) Ophthalmic SolutionUSB005 (aclerastide) Ophthalmic Solution 0.45%; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) |
| USB005 Placebo | Placebo comparator | Drug: USB005 Ophthalmic Solution PlaceboUSB005 Ophthalmic Solution Placebo; single eye drop instillation three times a day to one eye during a 28-day treatment period (84 treatments) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male or female volunteers, aged 18-64 years (inclusive) at the time of signing the ICF;
- For females:
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USB005 (aclerastide) Ophthalmic SolutionAclerastide ([Nle3]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP. | Drug | USB005 0.03%, USB005 0.1%, USB005 0.3%, USB005 0.45% |
| USB005 Ophthalmic Solution PlaceboA clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution. | Drug | USB005 Placebo |
Primary outcome
Percentage of volunteers with dose limiting toxicities in each cohort
Time frame: 36 days
Percentage of volunteers in each cohort with ocular adverse events
Time frame: 36 days
Percentage of volunteers in each cohort with systemic adverse events
Time frame: 36 days
Percentage of volunteers with clinically significant out of range laboratory values
Time frame: 36 days
6 secondary outcomes
Maximum observed concentrations (Cmax)
Time frame: 36 days
Time to reach maximum observed plasma concentration (Tmax) after multiple ascending dose
Time frame: 36 days
Apparent terminal half-life (T1/2) after multiple ascending dose
Time frame: 36 days
Area under the plasma concentration versus time curve from time 0 to infinity (AUCinf)
Time frame: 36 days
Area under the plasma concentration versus time curve up to the last measurable concentration (AUC0-last)
Time frame: 36 days
Apparent clearance (CL/F)
Time frame: 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 27116546Abdallah WF, Louie SG, Zhang Y, Rodgers KE, Sivok E, S diZerega G, Humayun MS. NorLeu3A(1-7) Accelerates Clear Corneal Full Thickness Wound Healing. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):2187-94. doi: 10.1167/iovs.15-18515.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sheety, MD principal investigator
WCCT Global, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing USB005 (aclerastide) Ophthalmic Solution in people with Healthy Volunteers, run by US Biotest, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of volunteers with dose limiting toxicities in each cohort (time frame: 36 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.