A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a Phase 1a/1b, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of prosetin administered to healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ProJenX
• Collaborator: Worldwide Clinical Trials

Criteria

Key Inclusion Criteria:

• Adults between 18 and 65 years of age, inclusive

• BMI within 18.0 to 32.0 kg/m2, inclusive

• In good health, in the opinion of the Investigator, as determined by a physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments

• Females of childbearing potential must agree to an approved method of contraception

Key Exclusion Criteria:

• History or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, neurological, or psychiatric disorder

• Any episodes of vertigo in the previous 12 months prior to screening or any medical history of seizures

• Active autoimmune conditions such as systemic lupus erythematosus

• A diagnosis of cancer or evidence of continued disease within five years before screening