CC-42344 Phase 1 Safety and PK Study in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.

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

Details

• Lead Sponsor: Cocrystal Pharma, Inc.
• Collaborators: Cocrystal Pharma Australia Pty Ltd.; Linear Clinical Research

Criteria

Inclusion Criteria (main):

• Healthy males or healthy, non-pregnant, non-lactating females

• Body weight of at least 50 kg

• Body mass index between ≥18.0 and ≤32.0 kg/m2

• Good state of health (mentally and physically)

• Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy

Exclusion Criteria (main):

• Have received any investigational drug in a clinical research study within the previous 30 days before screening

• Have received a coronavirus disease 2019 (COVID-19) vaccine within 2 weeks prior to randomization

• History of any drug or alcohol abuse in the past 2 years

• Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study

• Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator