A phase 1, single center, placebo-controlled, interventional study to evaluate the safety, tolerability, and pharmacokinetic profiles in healthy subjects compared to placebo

OliX Pharmaceuticals, Inc.0 sites48 target enrollmentMay 18, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: OliX Pharmaceuticals, Inc.
Enrollment: 48
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 18, 2018

End Date

June 27, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

OliX Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
•2\. Body mass index (BMI) between 18\.0 and 32\.0 kg/m2, inclusive, at Screening
•3\. In good health, determined by no clinically significant findings from medical history, physical examination, 12\-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non\-haemolytic hyperbilirubinaemia \[e.g., Gilbert’s syndrome] is not acceptable) at Screening and/or Check\-in as assessed by the Investigator (or designee)
•4\. Female subjects will be non\-pregnant and non\-lactating
•5\. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion Criteria

•1\. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (i.e., a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check\-in until 90 days after the Follow\-up Visit
•2\. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e., a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow\-up Visit. a. For Groups A1 to A4 only, females must be postmenopausal or have had a hysterectomy
•3\. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
•4\. Subjects with serum creatinine \>ULN
•5\. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
•6\. History of alcoholism or drug/chemical abuse within 2 years prior to Check\-in
•7\. Alcohol consumption of \>28 units per week for males and \>21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits
•8\. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check\-in
•9\. Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator
•10\. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half\-lives, whichever is longer) prior to Check\-in