Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers

Inclusion Criteria

• Participant eligibility is determined according to the following criteria prior to entry into the study:
• In the investigator's opinion, the participant can understand and sign the Informed Consent Form and comply with all protocol requirements.
• The participant is a healthy male or female adult who is 18 to 55 years of age, inclusive at the time of ICF.
• Participant weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 32.0 kg/m2, inclusive at Screening.
• A male participant who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing the ICF throughout the study and for 12 weeks after the last dose.

*Definitions and acceptable methods of contraception are defined in Section 9.1.9 Contraception and Pregnancy Avoidance Procedure, and reporting responsibilities are defined in Section 9.1.10 Pregnancy.

• A female participant of childbearing potential who complies with contraception requirements* or a female with no childbearing potential, defined as the participant has been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH>40 IU/L).

Exclusion Criteria: Any participant who meets any of the following criteria will not qualify for entry into the study:

• Participant has received any investigational compound within 30 days prior to the first dose of study medication or within 5 half-lives, whichever is greater.
• Participant is a study site employee or an immediate family member of a study site employee.
• Participant has evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, full-body allergic skin rash (including hives), psychiatric disorder, or other abnormality that may impact the ability of the participant to participate or potentially confound the study results.
• There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking CVN766 or a similar drug in the same class or that might interfere with the conduct of the study.
• Participant has a known hypersensitivity to any component of the formulation of CVN766.
• Participant has a positive urine result for drugs of abuse at Screening or Inpatient Check-in (Day -1).
• Participant has a history of drug abuse or a history of alcohol abuse (more than 14 units/week) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table as listed in Table 3: Excluded Medications and Dietary Products.
• Male participants who do not agree to all the following rules: when sexually active with a female partner(s) of childbearing potential during the study, and for 12 weeks after the last dose of study drug: a) must use an acceptable method of birth control (condom or surgical sterilization) and b) refrain from sexual activity with female partners who do not use an acceptable method of birth control. Barrier contraception (condom) must be used by all-male participants who were not surgically sterilized at least 90 days prior to screening. Male participants must also agree to refrain from sperm donation during the study and until 12 weeks after the last dose of study drug.
• Female participants who are pregnant or breastfeeding or plan to become pregnant or donate ova during the study or 30 days after the last dose of the study drug. Women of childbearing potential must agree to practice an acceptable method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence).

*