Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder

Inclusion Criteria

• Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
• Female subjects of child-bearing potential who are sexually active with males must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 30 days after the last dose of Investigational Medicinal Product (IMP). The impact of IMP on the efficacy of hormonal contraceptives is unknown. Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of IMP and agree to not donate sperm over this time period. Effective methods of contraception are:
• Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
• Progestogen-only hormonal contraception: oral, injectable/implantable, or intrauterine hormone-releasing system (IUD)
• Implantable intrauterine device (IUS)
• Surgical sterilization (for example, vasectomy or bilateral tubal ligation)
• Male condom with spermicidal gel/foam or with female cap or diaphragm (double barrier)
• abstinence from heterosexual intercourse as a conscious choice and established pattern of lifestyle

Part I and II only:

• Healthy male or female.
• Between 18 and 55 years of age inclusive.
• Body mass index (BMI) within 18.0 to 32.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).

Part III only:

• Male or female seeking treatment for OUD with a diagnosis of moderate or severe OUD by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
• Between 18 and 65 years of age inclusive.
• BMI within 18.0 to 35.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).

Exclusion Criteria

• Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.
• Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator or medically responsible physician.
• Have a history of narcolepsy or other significant sleep disorders.
• Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes.
• Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
• Serious cardiac illness or other cardiac assessments including, but not limited to:
• Uncontrolled arrhythmias.
• History of congestive heart failure (CHF).
• Myocardial infarction 450 msec for males and > 470 msec for females or history of prolonged QT syndrome.
• Current active hepatic or biliary disease, including subjects with cholecystectomy 21 units per week and females > 14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
• Positive test result for alcohol and/or any drugs of abuse at screening
• Have a blood pressure reading outside of the following range: Systolic 149 mmHg; Diastolic 94 mmHg
• Current smokers and those who have smoked within the last 90 days. Current users of e-cigarettes and nicotine replacement products, and those who have used these products within the last 90 days.
• Blood donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin ( 27 units per week and females > 20 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
• Current substance use disord