A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous in Healthy Volunteers
Condition: Healthy
Intervention: OP-101
Intervention description: Subcutaneous injection of OP-101 in healthy volunteers
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After
      Subcutaneous Administration in Healthy Volunteers
    

Eligibility criteria:

        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 screening and/or
             Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed
             at the discretion of the Investigator;

          -  Has had an acute illness considered clinically significant by the Investigator within
             30 days prior to screening;

          -  History of alcoholism or drug abuse within 2 years prior to screening;

          -  Has used any product containing nicotine within 90 days prior to screening or intends
             to use any product containing nicotine during the course of the study;

          -  Has had any immunizations (live vaccines) in the 4 weeks prior to screening;

          -  Has used medications that affect GI motility or gastric emptying; such as
             metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day
             1;

          -  Has used any prescription or over-the-counter medication (with exception of
             acetaminophen), vitamins/herbal supplements (with the exception of hormonal
             contraceptives) within 14 days prior to Day 1;

          -  Has used any other study drug within 30 days or 5 half-lives of the drug (whichever is
             longer) prior to Day 1;

          -  Has lost or donated >450 mL of whole blood or blood products within 30 days prior to
             screening;

          -  Investigator has reason to believe that the subject may be unable to fulfill the
             protocol visit schedule or requirements;

          -  Has any finding that, in the view of the Investigator or Medical Monitor, would
             compromise the subject's safety requirements; or

          -  Is employed by the Sponsor, the Contract Research Organization (CRO), or the study
             site (permanent, temporary contract worker, or designee responsible for the conduct of
             the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor,
             CRO, or study site employee.