Clinical trial NCT05977140: CDI-988 Safety Study in Healthy Participants
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Coronavirus
SARS-CoV-2
Lead sponsor: Cocrystal Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cocrystal Pharma Australia Pty Ltd.
name: Beyond Drug Development Pty Ltd.
name: Resolutum Global Pty Ltd.
name: Scientia Clinical Research Pty Ltd
First posted: 2023-08-04
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed description: CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will entail escalating single doses in sequential cohorts and Part 2 will enroll escalating multiple-dose cohorts. Participants will be monitored for adverse events, vital signs, laboratory values, and electrocardiograms (ECGs).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adverse events
timeFrame: Day 1 to 7 days after last dose
measure: Laboratory abnormalities
timeFrame: Day 1 to 7 days after last dose
measure: Vital signs
timeFrame: Day 1 to 7 days after last dose
measure: ECGs
timeFrame: Day 1 to 7 days after last dose
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 1 to 3 days after last dose
measure: Time of maximum plasma concentration (Tmax)
timeFrame: Day 1 to 7 days after last dose
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1 to 3 days after last dose
measure: Elimination rate constant (lambda Z)
timeFrame: Day 1 to 3 days after last dose
measure: Terminal elimination half-life (t1/2)
timeFrame: Day 1 to 3 days after last dose
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research Pty Ltd
state: New South Wales
Study officials:
affiliation: Scientia Clinical Research
name: Christopher Argent, MD
role: PRINCIPAL_INVESTIGATOR
References: