A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous in Healthy Volunteers

Inclusion Criteria

• Is a healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit;
• Has the ability to understand and sign the written Informed Consent Form (ICF) and local medical privacy authorization forms, which must be obtained prior to any study related procedures being completed;
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
• Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator;
• Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges;
• Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male subjects must use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 30 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
• Acceptable methods of contraception for male subjects enrolled in the study include the following:
• Condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (vasectomy);
• Acceptable methods of contraception for female subjects enrolled in the study include the following:
• Surgical sterilization of subject at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, oophorectomy, or salpingectomy);
• Intrauterine device for at least 12 weeks before the Screening Visit;
• Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit; or
• Diaphragm;
• If male, subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of study drug;
• Female subjects may not be pregnant, lactating, or breastfeeding;
• Female subjects of childbearing potential must have negative result for pregnancy test at screening and Check-in;
• Subjects must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVab), and human immunodeficiency virus (HIV) antibody at screening;
• Subjects must have an estimated glomerular filtration rate (eGFR) of ≥90 mL/min/1.73m2 at screening;
• Subjects must have a negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, and phencyclidine), cotinine, and breath alcohol test at screening and Check-in; and
• Subjects must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria

• Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study;
• History of malignancy (other than successfully treated basal cell or squamous cell skin cancer);
• History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant;
• Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) above the upper limit of normal at scree