Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.

Official Title
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A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACU-4429
* Drug: matching placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males or females, between 25 and 55 years of age, inclusive within BMI range 19 to 32 kg/m2 at Screening in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs; clinical laboratory evaluations (including serum for Chem-20 [fasted at least 10 hours], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator; Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study. able to comprehend and willing to sign an Informed Consent Form. Exclusion Criteria: significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator); history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator; history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed; history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant; participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in; Is currently using, or has recently received treatment with a medication disallowed by the Protocol.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACU-4429 tablet<br> | Drug: ACU-4429<br>* administered orally once a day for 14 days<br>|
| Placebo Comparator: matching placebo tablet<br> | Drug: matching placebo tablet<br>* administered orally once a day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by plasma ACU-4429 drug levels |  | 16 days |