Overview

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