CC-42344 Safety Study in Healthy Participants

Phase 1CompletedNCT05202379

Cocrystal Pharma, Inc.80 enrolled

Overview

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

This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts. Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug. Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Influenza A

Interventions

CC-42344DRUG

CC-42344 capsules

PlaceboDRUG

Placebo capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 any vaccine within 7 days 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

Locations (1)

Linear Clinical Research

Nedlands, Western Australia, Australia

Outcomes

Primary Outcomes

Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.

Time frame: Up to 16 days

Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities

Number of participants with clinically significant laboratory abnormalities was reported.

Time frame: Up to 16 days

Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs

Number of participants with clinically significant changes from baseline in vital signs was reported

Time frame: Up to 16 days

Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)

Number of participants with clinically significant changes from baseline in ECG was reported

Time frame: Up to 16 days

Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Time frame: Up to 21 days

Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities

Number of participants with clinically significant laboratory abnormalities was reported

Time frame: Up to 21 days

Data from ClinicalTrials.gov

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