An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers

This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose
study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of
VTP-43742 in healthy volunteers conducted at a single, study center in the United States
(Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40
healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1
of the study only; Part 2 is reported separately.

Inclusion Criteria:

- Healthy males or females, 18 to 45 years of age, inclusive.

- Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.

- Medically healthy with clinically insignificant screening results.

- Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must
agree that they and/or their partner will use two reliable forms of contraception as
per study requirements

- WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline
visit.

- Voluntarily consent to participate in the trial

Exclusion Criteria:

- Unwilling or unable to provide written informed consent

- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic,
neurologic, or psychiatric disease

- Evidence of organ dysfunction or any clinically significant deviation from normal in
vital signs, physical examination, clinical laboratory determinations or ECG

- Any major surgery within 3 months of Screening

- Positive urine drug/alcohol testing at Screening or Baseline visit

- Use of tobacco and/or nicotine-containing products within 3 months prior to the start
of dosing of the trial

- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C antibodies (HCV Ab) at Screening

- History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic
Criteria for Drug and Alcohol Abuse

- History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug
classes

- Any previous gastrointestinal surgery or recent (within 3 months) history of
gastrointestinal disease that could impact the absorption of the study drug

- Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial

- Plasma donation within 7 days prior to Day 1 of the trial

- Blood transfusion within 4 weeks of Screening

- Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical disease (e.g., infectious disease) must
not be enrolled into this study

- Any other medical, psychiatric, and/or social reason as determined by the Investigator