Hepatitis Clinical Trials

• Males or females aged 18 to 65 years (inclusive)

• Clinical diagnosis of sAH based on all the following:

∙ History of ongoing excess alcohol (\>60 g/day \[male\] or \>40 g/day \[female\]) use for ≥6 months, with \<60 days of abstinence prior to the onset of jaundice

‣ Serum total bilirubin \>3.0 mg/dL

‣ Aspartate aminotransferase (AST) ≥50 U/L

‣ AST/Aspartate aminotransferase (ALT) ratio ≥1.5

‣ Onset of jaundice within prior 8 weeks

‣ Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70

‣ Cohort 5 and Cohort 6: mDF ≥32

• Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30

• Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows:

‣ Surgical sterilization (bilateral tubal occlusion, etc.)

⁃ Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system \[IUS\])

⁃ Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation:

• Oral

∙ Intravaginal

∙ Transdermal

⁃ Progesterone-only hormonal contraception associated with inhibition of ovulation:

• Oral

∙ Injectable

∙ Implantable

⁃ Sexual abstinence: When in line with the preferred and usual lifestyle of the participant, is defined as avoiding all types of activity that could result in conception (pregnancy) from the initiation of Screening and until at least 90 days after the last dose of investigational product

• Male participants who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use 1 other approved method of highly effective contraception from the initiation of Screening and until at least 90 days after the dose of investigational product as listed in Inclusion Criteria #3.

• Male participants must refrain from sperm donation from the initiation of Screening and until at least 90 days after the last dose of investigational product

• Must provide written informed consent and agree to comply with the study protocol. In participants with hepatic encephalopathy which may impair decision-making, consent will be obtained per hospital procedures (e.g., by Legally Authorized Representative).

• Participants must agree to participate in an alcohol use disorder program during the study period, as recommended by the local institution's addiction medicine specialists, including post-hospitalization