CDI-988 Safety Study in Healthy Participants

NCT05977140 | Completed Phase 1 DMC

• 1 other identifier: CDI-988-P1-001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers. The main questions it aims to answer are:

• Are there any side effects of the drug?
• What is the amount of drug that reaches the bloodstream? Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams, electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.

Conditions

Healthy Volunteers

Keywords

Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• Adverse events

  number of participants with treatment-emergent adverse events

  Day 1 to 7 days after last dose

• Laboratory abnormalities

  number of participants with clinically significant laboratory abnormalities

  Day 1 to 7 days after last dose

• Vital signs

  number of participants with clinically significant changes from baseline in vital signs

  Day 1 to 7 days after last dose

• ECGs

  number of participants with clinically significant changes from baseline in ECGs

  Day 1 to 7 days after last dose

Secondary Outcomes (5)

• Maximum plasma concentration (Cmax)

  Day 1 to 3 days after last dose

• Time of maximum plasma concentration (Tmax)

  Day 1 to 7 days after last dose

• Area under the plasma concentration-time curve (AUC)

  Day 1 to 3 days after last dose

• Elimination rate constant (lambda Z)

  Day 1 to 3 days after last dose

• Terminal elimination half-life (t1/2)

  Day 1 to 3 days after last dose

Study Arms (12)

SAD Cohort 1A

EXPERIMENTAL

first single-dose level

Drug: CDI-988; Drug: Placebo

SAD Cohort 1B

EXPERIMENTAL

second single-dose level

Drug: CDI-988; Drug: Placebo

SAD Cohort 1C

EXPERIMENTAL

third single-dose level; food-effect cohort

Drug: CDI-988; Drug: Placebo

SAD Cohort 1D

EXPERIMENTAL

fourth single-dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2A

EXPERIMENTAL

first multiple-dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2B

EXPERIMENTAL

second multiple-dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2C

EXPERIMENTAL

third multiple-dose level

Drug: CDI-988; Drug: Placebo

SAD Cohort 1E

EXPERIMENTAL

fifth dose level; food effect cohort

Drug: CDI-988; Drug: Placebo

SAD Cohort 1F

EXPERIMENTAL

sixth dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2D

EXPERIMENTAL

4th multiple dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2E

EXPERIMENTAL

5th multiple dose level

Drug: CDI-988; Drug: Placebo

MAD Cohort 2F

EXPERIMENTAL

6th multiple dose level

Drug: CDI-988; Drug: Placebo

Interventions

CDI-988 DRUG

SARS-CoV-2 3CL protease inhibitor

MAD Cohort 2A; MAD Cohort 2B; MAD Cohort 2C; MAD Cohort 2D; MAD Cohort 2E; MAD Cohort 2F; SAD Cohort 1A; SAD Cohort 1B; SAD Cohort 1C; SAD Cohort 1D; SAD Cohort 1E; SAD Cohort 1F

Placebo DRUG

matching placebo

MAD Cohort 2A; MAD Cohort 2B; MAD Cohort 2C; MAD Cohort 2D; MAD Cohort 2E; MAD Cohort 2F; SAD Cohort 1A; SAD Cohort 1B; SAD Cohort 1C; SAD Cohort 1D; SAD Cohort 1E; SAD Cohort 1F

Eligibility Criteria

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

You may qualify if:

• Healthy males or non-pregnant, non-lactating females
• Body weight of at least 45 kg.
• Body mass index ≥18.0 and ≤32.0 kg/m2
• Good state of mental and physical health
• Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test

You may not qualify if:

• Received an investigational drug within 30 days
• Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days
• Drug or alcohol abuse in the past 12 months
• Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results
• Clinically significant abnormal ECG or vital signs

Sponsors & Collaborators

• Cocrystal Pharma, Inc.: lead
• Cocrystal Pharma Australia Pty Ltd.: collaborator
• Beyond Drug Development Pty Ltd.: collaborator
• Resolutum Global Pty Ltd.: collaborator
• Scientia Clinical Research Pty Ltd: collaborator

Study Sites (1)

Scientia Clinical Research Pty Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Christopher Argent, MD

  Scientia Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: 5 randomized single ascending dose cohorts of 8 participants and 1 open-label single ascending dose cohort of 6 participants. In Part 2, 6 multiple ascending dose cohorts, each with 8 participants

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: September 27, 2023
• Primary Completion: May 23, 2025
• Study Completion: July 23, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)