Safety assessment of CDI-988 in healthy volunteers
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
PHASE1 · Cocrystal Pharma, Inc. · NCT05977140
This study is testing a new drug called CDI-988 in healthy volunteers to see if it's safe and how the body processes it.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Cocrystal Pharma, Inc. (industry) |
| Locations | 1 site (Randwick, New South Wales) |
| Trial ID | NCT05977140 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and pharmacokinetics of a new drug called CDI-988 in healthy participants. The study is divided into two parts: the first part involves escalating single doses, while the second part focuses on escalating multiple doses. Participants will be randomly assigned to receive either CDI-988 or a placebo, and will undergo physical exams, ECGs, vital signs monitoring, and blood tests to assess any potential side effects. The goal is to determine the drug's safety profile and how it is processed in the body.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males or non-pregnant, non-lactating females aged 18 years and older with a body weight of at least 45 kg.
Not a fit: Patients with a history of drug or alcohol abuse, significant health issues, or recent vaccinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data for CDI-988, potentially leading to its use in treating COVID-19.
How similar studies have performed: Other studies evaluating similar pharmacological approaches have shown promise, but this specific drug and its safety profile are novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Randwick, New South Wales
- Scientia Clinical Research Pty Ltd — Randwick, New South Wales, Australia (RECRUITING)
Study contacts
- Principal investigator: Christopher Argent, MD — Scientia Clinical Research
- Study coordinator: Sam Lee, PhD
- Email: slee@cocrystalpharma.com
- Phone: 425-750-7208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteers, Coronavirus, SARS-CoV-2