Healthy SubjectsPhase 1NCT04788017
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
A Phase 1 study testing Ziresovir in people with Healthy Subjects, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ziresovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 22 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
- Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.
Who cannot join
- Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Poor venous access;
- Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
- Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.
Read the detailed description
Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.
The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.
- Conditions
- Healthy Subjects
- Being tested
- Ziresovir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiresovirDrug
Also called AK0529
Planned treatments are:
- Cohort 1: 300 mg of ziresovir
- Cohort 2: up to 600 mg of ziresovir
- Cohort 3: up to 900 mg of ziresovir
PlaceboOther
Planned treatments are:
- Cohort 1: 300 mg of placebo
- Cohort 2: up to 600 mg of placebo
- Cohort 3: up to 900 mg of placebo
| Study group | Role | What they receive |
|---|---|---|
| ziresovir | Active comparator | The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.
Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
* If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
* If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
* If administered 180 mL as the study drug dose, follow with approximately 60 mL water. Receives: Drug: Ziresovir |
| placebo | Placebo comparator | The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.
Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:
* If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
* If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
* If administered 180 mL as the study drug dose, follow with approximately 60 mL water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of all AEs
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
Measured: through study completion, an average of 22 days
percentages of all AEs
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
Measured: through study completion, an average of 22 days
change from baseline in systolic and diastolic blood pressure
blood pressure in millimeter of mercury
Measured: screen/day -1/day 1/day 2/day 3/day4
change from baseline in pulse rate
pulse rate in times per minute
Measured: screen/day -1/day 1/day 2/day 3/day4
change from baseline in respiratory rate
respiratory rate in times per minute
Measured: screen/day -1/day 1/day 2/day 3/day4
change from baseline in oral temperature
oral temperature in degree
Measured: screen/day -1/day 1/day 2/day 3/day4
change from baseline in Prothrombin time/International Normalized Ratio
INR is calculated from the PT and allows for worldwide standardization of results.
Measured: screen/day -1/day 2/day4
change from baseline in Thrombin time
Thrombin time in seconds
Measured: screen/day -1/day 2/day4
change from baseline in activated Partial Thromboplastin time
activated Partial Thromboplastin time in seconds
Measured: screen/day -1/day 2/day4
change from baseline in Hemoglobin (Hgb) count
Hemoglobin (Hgb) in gram per liter
Measured: screen/day -1/day 2/day4
change from baseline in Hematocrit (Hct)
Measured: screen/day -1/day 2/day4
change from baseline in Platelet count
Platelet count per liter
Measured: screen/day -1/day 2/day4
change from baseline in Red blood cell (RBC) count
Measured: screen/day -1/day 2/day4
change from baseline in White blood cell (WBC) count with differential
Measured: screen/day -1/day 2/day4
change from baseline in Specific gravity from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in pH from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Protein from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Glucose from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Ketones from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Bilirubin from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Blood from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Nitrites from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Leukocytes from urinalysis
Measured: screen/day -1/day 2/day4
change from baseline in Urobilinogen from urinalysis
Measured: screen/day -1/day 2/day4
Incidence of abnormal Microscopic urine analysis
Measured: screen/day -1/day 2/day4
change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
ECGs will be performed after the subject has been supine for at least 5 minutes
Measured: screen/day -1/day1/day2/day4
change from baseline in heart rate from resting 12-lead ECGs
ECGs will be performed after the subject has been supine for at least 5 minutes
Measured: screen/day -1/day1/day2/day4
change from baseline in QRS intervals from resting 12-lead ECGs
ECGs will be performed after the subject has been supine for at least 5 minutes
Measured: screen/day -1/day1/day2/day4
change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
ECGs will be performed after the subject has been supine for at least 5 minutes
Measured: screen/day -1/day1/day2/day4
change from baseline in appearance of U-waves from resting 12-lead ECGs
ECGs will be performed after the subject has been supine for at least 5 minutes
Measured: screen/day -1/day1/day2/day4
Incidence of abnormal physical findings
full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
Measured: screen/day -1/day2/day3/day4
Secondary outcomes (1)
To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Measured: 0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start24 Mar 2021
- Primary completion14 Jun 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jimmy Gu, Study director, Ark Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788017
- Sponsor's protocol ID
- AK0529-3001
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04788017
- Acronym / sponsor ID
- AK0529-3001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.
Detailed description
Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.
The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.
A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ziresovir | Active comparator | Drug: ZiresovirThe study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows: * If administered 60 mL as the study drug dose, follow with approximately 180 mL water. * If administered 120 mL as the study drug dose, follow with approximately 120 mL water. * If administered 180 mL as the study drug dose, follow with approximately 60 mL water. |
| placebo | Placebo comparator | Other: PlaceboThe study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast. Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows: * If administered 60 mL as the study drug dose, follow with approximately 180 mL water. * If administered 120 mL as the study drug dose, follow with approximately 120 mL water. * If administered 180 mL as the study drug dose, follow with approximately 60 mL water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Capable of giving written informed consent and complying with study procedures;
- Between the ages of 18 and 55 years, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- Female subjects must have a negative pregnancy test result at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
Key exclusion criteria (6 listed)
- Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Poor venous access;
- Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
- Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
- Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
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 |
|---|---|---|
| ZiresovirAlso: AK0529Planned treatments are: * Cohort 1: 300 mg of ziresovir * Cohort 2: up to 600 mg of ziresovir * Cohort 3: up to 900 mg of ziresovir | Drug | ziresovir |
| PlaceboPlanned treatments are: * Cohort 1: 300 mg of placebo * Cohort 2: up to 600 mg of placebo * Cohort 3: up to 900 mg of placebo | Other | placebo |
Primary outcome
numbers of all AEs
Time frame: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
percentages of all AEs
Time frame: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
change from baseline in systolic and diastolic blood pressure
Time frame: screen/day -1/day 1/day 2/day 3/day4
blood pressure in millimeter of mercury
change from baseline in pulse rate
Time frame: screen/day -1/day 1/day 2/day 3/day4
pulse rate in times per minute
change from baseline in respiratory rate
Time frame: screen/day -1/day 1/day 2/day 3/day4
respiratory rate in times per minute
change from baseline in oral temperature
Time frame: screen/day -1/day 1/day 2/day 3/day4
oral temperature in degree
change from baseline in Prothrombin time/International Normalized Ratio
Time frame: screen/day -1/day 2/day4
INR is calculated from the PT and allows for worldwide standardization of results.
change from baseline in Thrombin time
Time frame: screen/day -1/day 2/day4
Thrombin time in seconds
change from baseline in activated Partial Thromboplastin time
Time frame: screen/day -1/day 2/day4
activated Partial Thromboplastin time in seconds
change from baseline in Hemoglobin (Hgb) count
Time frame: screen/day -1/day 2/day4
Hemoglobin (Hgb) in gram per liter
change from baseline in Hematocrit (Hct)
Time frame: screen/day -1/day 2/day4
change from baseline in Platelet count
Time frame: screen/day -1/day 2/day4
Platelet count per liter
change from baseline in Red blood cell (RBC) count
Time frame: screen/day -1/day 2/day4
change from baseline in White blood cell (WBC) count with differential
Time frame: screen/day -1/day 2/day4
change from baseline in Specific gravity from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in pH from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Protein from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Glucose from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Ketones from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Bilirubin from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Blood from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Nitrites from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Leukocytes from urinalysis
Time frame: screen/day -1/day 2/day4
change from baseline in Urobilinogen from urinalysis
Time frame: screen/day -1/day 2/day4
Incidence of abnormal Microscopic urine analysis
Time frame: screen/day -1/day 2/day4
change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
Time frame: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
change from baseline in heart rate from resting 12-lead ECGs
Time frame: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
change from baseline in QRS intervals from resting 12-lead ECGs
Time frame: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
Time frame: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
change from baseline in appearance of U-waves from resting 12-lead ECGs
Time frame: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
Incidence of abnormal physical findings
Time frame: screen/day -1/day2/day3/day4
full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
1 secondary outcome
To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Time frame: 0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- 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.
Jimmy Gu study director
Ark Biosciences
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 Ziresovir in people with Healthy Subjects, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in United States.
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 6 inclusion and 6 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 15 Feb 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
numbers of all AEs (time frame: through study completion, an average of 22 days). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.