CC-42344 Safety Study in Healthy Participants

NCT05202379 | Completed Phase 1 Results DMC

• 1 other identifier: CC-42344-P1-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza A

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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

  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

  Up to 16 days

• Part 2 MAD: 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.

  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

  Up to 21 days

• Part 2 MAD: 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

  Up to 21 days

• Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)

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

  Up to 14 days

Secondary Outcomes (14)

• Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344

  Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

• Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344

  Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

• Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344

  Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

• Part 1 SAD: Elimination Rate Constant (λz) of CC-42344

  Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

• Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344

  Day 1: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose

Study Arms (9)

SAD cohort 1A

EXPERIMENTAL

first dose level with 6 active and 2 placebo healthy participants

Drug: CC-42344; Drug: Placebo

SAD cohort 1B

EXPERIMENTAL

second dose level with 6 active and 2 placebo healthy participants

Drug: CC-42344; Drug: Placebo

SAD cohort 1C

EXPERIMENTAL

third dose level with 12 active and 2 placebo healthy participants; food-effect cohort

Drug: CC-42344; Drug: Placebo

SAD cohort 1D

EXPERIMENTAL

fourth dose level with 6 active and 2 placebo healthy participants

Drug: CC-42344; Drug: Placebo

MAD cohort 2A

EXPERIMENTAL

first dose level with 6 active and 2 placebo healthy participants dose x 14 days

Drug: CC-42344; Drug: Placebo

MAD cohort 2B

EXPERIMENTAL

second dose level with 6 active and 2 placebo healthy participants dose x 14 days

Drug: CC-42344; Drug: Placebo

MAD cohort 2C

EXPERIMENTAL

third dose level with 6 active and 2 placebo healthy participants dose x 14 days

Drug: CC-42344; Drug: Placebo

MAD cohort 2D

EXPERIMENTAL

forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Drug: CC-42344; Drug: Placebo

MAD cohort 2E

EXPERIMENTAL

forth dose level with 6 active and 2 placebo healthy participants dose x 5 days

Drug: CC-42344; Drug: Placebo

Interventions

Placebo DRUG

Placebo capsules

MAD cohort 2A; MAD cohort 2B; MAD cohort 2C; MAD cohort 2D; MAD cohort 2E; SAD cohort 1A; SAD cohort 1B; SAD cohort 1C; SAD cohort 1D

CC-42344 DRUG

CC-42344 capsules

Also known as: Active

MAD cohort 2A; MAD cohort 2B; MAD cohort 2C; MAD cohort 2D; MAD cohort 2E; SAD cohort 1A; SAD cohort 1B; SAD cohort 1C; SAD cohort 1D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cocrystal Pharma, Inc.: lead
• Cocrystal Pharma Australia Pty Ltd.: collaborator
• Linear Clinical Research: collaborator

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: David Huang, MD, PhD, Chief Medical Officer
• Organization: Cocrystal Pharma

dhuang@cocrystalpharma.com

936-577-5770

Study Officials

• Sam Salman, MD

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: active and placebo capsules identical visually.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: February 11, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)