Healthy VolunteersPhase 1NCT05977140

CDI-988 Safety Study in Healthy Participants

A Phase 1 study testing CDI-988 in people with Healthy Volunteers, run by Cocrystal Pharma, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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?… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: CDI-988
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteAustralia
Study dates: 27 Sep 2023to 23 Jul 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Scientia Clinical Research Pty Ltd
Randwick, New South Wales, 2031

Other trials in Australia

About this study

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

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.

Read the 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).

Conditions: Healthy Volunteers
Being tested: CDI-988, Placebo
Keywords: Coronavirus, SARS-CoV-2
Medical subject headings: Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CDI-988Drug
SARS-CoV-2 3CL protease inhibitor
PlaceboDrug
matching placebo

Study groups in NCT05977140
Study group	Role	What they receive
SAD Cohort 1A	Experimental	first single-dose level Receives: Drug: CDI-988; Drug: Placebo
SAD Cohort 1B	Experimental	second single-dose level Receives: Drug: CDI-988; Drug: Placebo
SAD Cohort 1C	Experimental	third single-dose level; food-effect cohort Receives: Drug: CDI-988; Drug: Placebo
SAD Cohort 1D	Experimental	fourth single-dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2A	Experimental	first multiple-dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2B	Experimental	second multiple-dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2C	Experimental	third multiple-dose level Receives: Drug: CDI-988; Drug: Placebo
SAD Cohort 1E	Experimental	fifth dose level; food effect cohort Receives: Drug: CDI-988; Drug: Placebo
SAD Cohort 1F	Experimental	sixth dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2D	Experimental	4th multiple dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2E	Experimental	5th multiple dose level Receives: Drug: CDI-988; Drug: Placebo
MAD Cohort 2F	Experimental	6th multiple dose level Receives: Drug: CDI-988; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
number of participants with treatment-emergent adverse events
Measured: Up to 17 days
Laboratory Abnormalities
number of participants with clinically significant laboratory abnormalities
Measured: Up to 17 days
Vital Signs
number of participants with clinically significant changes from baseline in vital signs
Measured: Day 1 to 7 days after last dose
ECGs
number of participants with clinically significant changes from baseline in ECGs
Measured: Day 1 to 7 days after last dose

Secondary outcomes (10)

Part 1 SAD Maximum Plasma Concentration (Cmax)
Cmax was evaluated from the PK samples collected
Measured: predose, 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)
Tmax was evaluated from the PK samples collected.
Measured: predose, 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 (AUC) From Time 0 to t (AUC0-t) of CDI-988
AUC0-t was evaluated from the PK samples collected
Measured: pre dose, 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 (Lambda Z)
λz was evaluated from the PK samples collected
Measured: predose, 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)
t1/2 was evaluated from the PK samples collected.
Measured: predose, 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 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988
Cmax was evaluated from the PK samples collected.
Measured: Day 1, Day 5 and Day 10: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48h post-dose
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988
Tmax was evaluated from the PK samples collected.
Measured: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h
Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988
AUC0-t was calculated from the PK samples collected
Measured: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h
Part 2 MAD: Elimination Rate Constant (λz) of CDI-988
λz was evaluated from the PK samples collected
Measured: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988
T1/2 was evaluated from the PK samples collected
Measured: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202323 Jul 2025

First posted4 Aug 2023
Study start27 Sep 2023
Primary completion23 May 2025
Study completion23 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05977140
Sponsor's protocol ID: CDI-988-P1-001
Status last verified: Aug 2026
First submitted: 28 Jul 2023
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05977140
Acronym / sponsor ID: CDI-988-P1-001
Conditions: Healthy Volunteers
Keywords: Coronavirus, SARS-CoV-2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Cocrystal Pharma, Inc.Industry (pharma, biotech, devices)
Collaborators: Cocrystal Pharma Australia Pty Ltd., Beyond Drug Development Pty Ltd., Resolutum Global Pty Ltd., Scientia Clinical Research Pty Ltd
Study start: 27 Sep 2023 (actual)
Primary completion: 23 May 2025 (actual)
Study completion: 23 Jul 2025 (actual)
First posted: 4 Aug 2023 (actual)
Results: Posted 19 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12
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

Arm	Type	Receives
SAD Cohort 1A	Experimental	Drug: CDI-988, Drug: Placebofirst single-dose level
SAD Cohort 1B	Experimental	Drug: CDI-988, Drug: Placebosecond single-dose level
SAD Cohort 1C	Experimental	Drug: CDI-988, Drug: Placebothird single-dose level; food-effect cohort
SAD Cohort 1D	Experimental	Drug: CDI-988, Drug: Placebofourth single-dose level
MAD Cohort 2A	Experimental	Drug: CDI-988, Drug: Placebofirst multiple-dose level
MAD Cohort 2B	Experimental	Drug: CDI-988, Drug: Placebosecond multiple-dose level
MAD Cohort 2C	Experimental	Drug: CDI-988, Drug: Placebothird multiple-dose level
SAD Cohort 1E	Experimental	Drug: CDI-988, Drug: Placebofifth dose level; food effect cohort
SAD Cohort 1F	Experimental	Drug: CDI-988, Drug: Placebosixth dose level
MAD Cohort 2D	Experimental	Drug: CDI-988, Drug: Placebo4th multiple dose level
MAD Cohort 2E	Experimental	Drug: CDI-988, Drug: Placebo5th multiple dose level
MAD Cohort 2F	Experimental	Drug: CDI-988, Drug: Placebo6th multiple dose level

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CDI-988SARS-CoV-2 3CL protease inhibitor	Drug	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
Placebomatching placebo	Drug	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

Primary outcome

Adverse Events
Time frame: Up to 17 days
number of participants with treatment-emergent adverse events
Laboratory Abnormalities
Time frame: Up to 17 days
number of participants with clinically significant laboratory abnormalities
Vital Signs
Time frame: Day 1 to 7 days after last dose
number of participants with clinically significant changes from baseline in vital signs
ECGs
Time frame: Day 1 to 7 days after last dose
number of participants with clinically significant changes from baseline in ECGs

10 secondary outcomes

Part 1 SAD Maximum Plasma Concentration (Cmax)
Time frame: predose, 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)
Time frame: predose, 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 (AUC) From Time 0 to t (AUC0-t) of CDI-988
Time frame: pre dose, 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 (Lambda Z)
Time frame: predose, 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)
Time frame: predose, 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 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988
Time frame: Day 1, Day 5 and Day 10: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48h post-dose
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988
Time frame: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h
Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988
Time frame: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h
Part 2 MAD: Elimination Rate Constant (λz) of CDI-988
Time frame: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988
Time frame: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h

Results and safety

Results posted to the registry on 19 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD Cohort 1A	6	6
SAD Cohort 1B	6	6
SAD Cohort 1C	6	6
SAD Cohort 1D	6	6
SAD Cohort 1E	6	6
SAD Cohort 1F	6	6
Part 1 SAD Placebo	10	10
MAD Cohort 2A	6	6
MAD Cohort 2B	6	6
MAD Cohort 2C	6	6
MAD Cohort 2D	6	6
MAD Cohort 2E	6	5
MAD Cohort 2F	6	5
Part 2 MAD Placebo	12	12

Primary outcome: Adverse Events

Time frame: Up to 17 days. Number. Unit: Participants

Measure	Part 1 SAD CDI-988 100mg Fasted n = 12	Part 1 SAD CDI-988 200mg Fasted n = 6	Part 1 SAD CDI-988 400mg Fasted n = 6	Part 1 SAD CDI-988 600mg Fasted n = 6	Part 1 SAD CDI-988 1200mg Fasted n = 6	Part 1 SAD Placebo n = 10	Part 1 SAD CDI-988 100mg Fed Day 9 n = 6	Part 1 SAD CDI-988 400mg Fed Day 9 n = 6	Part 1 SAD CDI-988 1200mg Fed Day 9 n = 6	Part 1 SAD Placebo Fed on Day 9 n = 4	Part 2 MAD CDI-988 200mg QD Fed n = 6	Part 2 MAD CDI-988 400mg QD Fed n = 6	Part 2 MAD CDI-988 800mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg BID Fed n = 6	Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted n = 6	Part 2 MAD Placebo n = 12
Value	2	2	2	3	2	4	0	1	0	1	3	3	3	2	3	5	11

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-9882 or placebo)

Primary outcome: Laboratory Abnormalities

Time frame: Up to 17 days. Number. Unit: Participants

Measure	Part 1 SAD CDI-988 100mg Fasted n = 12	Part 1 SAD CDI-988 200mg Fasted n = 6	Part 1 SAD CDI-988 400mg Fasted n = 6	Part 1 SAD CDI-988 600mg Fasted n = 6	Part 1 SAD CDI-988 1200mg Fasted n = 6	Part 1 SAD Placebo n = 10	Part 1 SAD CDI-988 100mg Fed Day 9 n = 6	Part 1 SAD CDI-988 400mg Fed Day 9 n = 6	Part 1 SAD CDI-988 1200mg Fed Day 9 n = 6	Part 1 SAD Placebo Fed on Day 9 n = 4	Part 2 MAD CDI-988 200mg QD Fed n = 6	Part 2 MAD CDI-988 400mg QD Fed n = 6	Part 2 MAD CDI-988 800mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg BID Fed n = 6	Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted n = 6	Part 2 MAD Placebo n = 12
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)

Primary outcome: Vital Signs

Time frame: Day 1 to 7 days after last dose. Number. Unit: Participants

Measure	Part 1 SAD CDI-988 100mg Fasted n = 12	Part 1 SAD CDI-988 200mg Fasted n = 6	Part 1 SAD CDI-988 400mg Fasted n = 6	Part 1 SAD CDI-988 600mg Fasted n = 6	Part 1 SAD CDI-988 1200mg Fasted n = 6	Part 1 SAD Placebo n = 10	Part 1 SAD CDI-988 100mg Fed Day 9 n = 6	Part 1 SAD CDI-988 400mg Fed Day 9 n = 6	Part 1 SAD CDI-988 1200mg Fed Day 9 n = 6	Part 1 SAD Placebo Fed on Day 9 n = 4	Part 2 MAD CDI-988 200mg QD Fed n = 6	Part 2 MAD CDI-988 400mg QD Fed n = 6	Part 2 MAD CDI-988 800mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg BID Fed n = 6	Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted n = 6	Part 2 MAD Placebo n = 12
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)

Primary outcome: ECGs

Time frame: Day 1 to 7 days after last dose. Number. Unit: Participants

Measure	Part 1 SAD CDI-988 100mg Fasted n = 12	Part 1 SAD CDI-988 200mg Fasted n = 6	Part 1 SAD CDI-988 400mg Fasted n = 6	Part 1 SAD CDI-988 600mg Fasted n = 6	Part 1 SAD CDI-988 1200mg Fasted n = 6	Part 1 SAD Placebo n = 10	Part 1 SAD CDI-988 100mg Fed Day 9 n = 6	Part 1 SAD CDI-988 400mg Fed Day 9 n = 6	Part 1 SAD CDI-988 1200mg Fed Day 9 n = 6	Part 1 SAD Placebo Fed on Day 9 n = 4	Part 2 MAD CDI-988 200mg QD Fed n = 6	Part 2 MAD CDI-988 400mg QD Fed n = 6	Part 2 MAD CDI-988 800mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg QD Fed n = 6	Part 2 MAD CDI-988 1200mg BID Fed n = 6	Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted n = 6	Part 2 MAD Placebo n = 12
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 17 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 SAD CDI-988 100mg Fasted	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Part 1 SAD CDI-988 200mg Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 SAD CDI-988 400mg Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 SAD CDI-988 600mg Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 SAD CDI-988 1200mg Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 1 SAD Placebo	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Part 1 SAD CDI-988 100mg Fed Day 9	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1 SAD CDI-988 400mg Fed Day 9	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 1 SAD CDI-988 1200mg Fed Day 9	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1 SAD Placebo Fed on Day 9	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Part 2 MAD CDI-988 200mg QD Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD CDI-988 400mg QD Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD CDI-988 800mg QD Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD CDI-988 1200mg QD Fed	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part 2 MAD CDI-988 1200mg BID Fed	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 2 MAD Placebo	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Argent, MD principal investigator

Scientia Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CDI-988 in people with Healthy Volunteers, run by Cocrystal Pharma, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to 17 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05977140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.