Covid19Phase 1NCT04679493
Study to Assess Safety, Tolerability and Pharmacokinetics of XC7 (Which is Planned Use in the Treatment of COVID-19) in Healthy Volunteers
A Phase 1 study testing XC7 100 mg single, XC7 200 mg single and XC7 200 mg multiple in people with Covid19 and Healthy Volunteers, run by NP Therapeutics at 1 site in Russia.
Trial summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Healthy Volunteers
- What is being tested?
- XC7 100 mg single, XC7 200 mg single and XC7 200 mg multiple
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 17 Dec 2020to 9 Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking men (nonsmokers at least within the last year before the screening) at the ages from 18 through 45;
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass index from 18.5 to 30.0 kg/m2 with body weight of more than 45 kg and no more than 110 kg;
- Negative result for alcohol vapor content in the exhaled air, narcotic substances in the urine;
- Agreement to use adequate contraception methods during the study and 3 months after its completion: condoms with spermicide (foam, gel, cream, suppository);
- Signed patient explanation sheet and informed consent for participation in the study.
Who cannot join
- Chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, musculoskeletal system, as well as the gastrointestinal tract, liver, kidneys, blood, mental illness, epilepsy or convulsive seizures;
- Abnormal results of standard laboratory tests and investigations at the screening visit;
- Gastrointestinal surgery (except for appendectomy) in the past medical history;
- Systolic blood pressure of less than 90 mm Hg or above 139 mm Hg, diastolic blood pressure of less than 60 mm Hg or above 90 mm Hg, heart rate of less than 60 bpm or above 90 bpm - at screening;
- Regular administration of drugs within 2 weeks prior to screening (including herbal agents and dietary supplements);
- Use of drugs with significant effect on hemodynamics, hepatic function, etc. (e.g. barbiturates, omeprazole, cimetidine, etc.) within 30 days prior to screening;
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- Antibodies to HIV and hepatitis C, hepatitis B surface antigen, positive test for syphilis;
- Unstable sleep architecture (e.g. night work, sleep disorders, insomnia, recently returned from another time zone, etc.), extreme physical activity (e.g. weight lifting);
- Special diet (for example, vegetarian, vegan, low calorie (less than 1000 kcal/day));
- Signs of alcohol abuse (intake of more than 10 units of alcohol per week) or 50 ml of hard alcohol; drinking alcohol within 4 days prior to screening;
- Signs of drug abuse; taking narcotic and psychotropic drugs (opiates/morphine, methamphetamine, amphetamine, cannabinoids/marijuana, cocaine, methadone, ecstasy, tricyclic antidepressants, barbiturates) at the moment and in the history;
- burdened past allergic history;
- Hypersensitivity to the components of the investigated drugs;
- Blood/plasma donation (from 450 ml blood or plasma) within 2 months prior to screening;
- Participation in other clinical studies within 3 months prior to screening;
- Acute infectious diseases within 4 weeks prior to screening;
- Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; noncompliance with the drugs administration or procedures schedule, which according to the researchers may affect the study results or the volunteer safety and prevent the further participation of the volunteer in the study; any other associated medical or serious mental conditions that make the volunteer inadequate for participation in the clinical study and restrict the validity of informed consent or may affect the volunteer's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Autonomous Educational Institution of Higher Education "The First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation
Moscow, 119991
About this study
Official title: Double Blind, Randomized, Placebo-controlled Study of Safety, Tolerability, and Pharmacokinetics of Ascending Doses of XC7 After Single and Multiple Oral Administration in Healthy Volunteers
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg) or placebo during 14 days (cohort ratio 6:2).
Read the detailed description
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days).
The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС7 or placebo once and stay at the study center for at least 24 hours after the ID administration to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7 days, during which safety parameters and PK in volunteers will be studied. Based on all safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will consider dose increase and entry of the 200 mg cohort. If the single dose of ХС7 200 mg is considered to be safe, the third multiple dosing cohort of 200 mg will be included in the study.
The volunteers from multiple dosing cohort will receive the ID (ХС7 or placebo) once a day during 14 days and will stay at the hospital (study center) during the first five days after administration of the ID. The Follow-up will last 14 days, during which they will study safety parameters and PK in volunteers.
- Conditions
- Covid19, Healthy Volunteers
- Being tested
- XC7 100 mg single, XC7 200 mg single, Placebo single, XC7 200 mg multiple, Placebo multiple
- Keywords
- Coronavirus, Phase I
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC7 100 mg singleDrug
The volunteers will receive a single dose of the ID (1 capsule once, 100 mg)
XC7 200 mg singleDrug
The volunteers will receive a single dose of the ID (2 capsules once, 100 mg each)
Placebo singleDrug
The volunteers will receive a single dose of the ID (1 or 2 capsules once)
XC7 200 mg multipleDrug
The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each)
Placebo multipleDrug
The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)
| Study group | Role | What they receive |
|---|---|---|
| XC7 100 mg single | Experimental | Cohort 1 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 100 mg (3 subjects) or placebo (1 subject, see placebo single arm) Receives: Drug: XC7 100 mg single |
| XC7 200 mg single | Experimental | Cohort 2 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 200 mg (3 subjects) or placebo (1 subject, see placebo single arm) Receives: Drug: XC7 200 mg single |
| Placebo single | Placebo comparator | Placebo comparator arm will consist of 2 subjects (1 subject from Сohorts 1 and 2) Receives: Drug: Placebo single |
| XC7 200 mg multiple | Experimental | Cohort 3 - 6 subjects will be randomized in a 6:2 ratio to be treated either XC7 200 mg (6 subjects) or placebo (1 subject, see placebo multiple arm) Receives: Drug: XC7 200 mg multiple |
| Placebo multiple | Placebo comparator | Placebo comparator arm will consist of 2 subjects from cohort 3 Receives: Drug: Placebo multiple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events (AEs) per treatment arm
Adverse events will be classified according to CTCAE ver 4.03. Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version.
Measured: Day -7 (7 days before first dose) - Day 58
Secondary outcomes (5)
Pharmacokinetics of XC7 by assessing AUC0-inf
Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity.
Measured: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Cmax
Maximum plasma concentration
Measured: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing AUC0-t
Area under the curve "concentration of the drug-time" from the time of administration of the drug till the time (t) the last blood sampling
Measured: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Tmax
Time to maximum drug concentration in the blood plasma administration
Measured: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing T1/2
Terminal elimination half-life
Measured: Day 1 - Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Dec 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- The dose cohorts cohorts will be included into the study subsequently based on preliminary safety results evaluation performed by the DSMC. 2 doses of XC7/placebo (100 mg, 200 mg) were used in the study.The duration of exposure to the ID is planned 1 day in single dosing cohorts and 14 days in multiple dosing cohort.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NP Therapeutics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679493
- Sponsor's protocol ID
- COVID-XC7-01
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo-controlled Study of Safety, Tolerability, and Pharmacokinetics of Ascending Doses of XC7 After Single and Multiple Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04679493
- Acronym / sponsor ID
- COVID-XC7-01
- Conditions
- Covid19, Healthy Volunteers
- Keywords
- Coronavirus, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NP TherapeuticsUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 22 Dec 2020 (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.
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg) or placebo during 14 days (cohort ratio 6:2).
Detailed description
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days).
The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС7 or placebo once and stay at the study center for at least 24 hours after the ID administration to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7 days, during which safety parameters and PK in volunteers will be studied. Based on all safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will consider dose increase and entry of the 200 mg cohort. If the single dose of ХС7 200 mg is considered to be safe, the third multiple dosing cohort of 200 mg will be included in the study.
The volunteers from multiple dosing cohort will receive the ID (ХС7 or placebo) once a day during 14 days and will stay at the hospital (study center) during the first five days after administration of the ID. The Follow-up will last 14 days, during which they will study safety parameters and PK in volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- The dose cohorts cohorts will be included into the study subsequently based on preliminary safety results evaluation performed by the DSMC. 2 doses of XC7/placebo (100 mg, 200 mg) were used in the study.The duration of exposure to the ID is planned 1 day in single dosing cohorts and 14 days in multiple dosing cohort.
| Arm | Type | Receives |
|---|---|---|
| XC7 100 mg single | Experimental | Drug: XC7 100 mg singleCohort 1 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 100 mg (3 subjects) or placebo (1 subject, see placebo single arm) |
| XC7 200 mg single | Experimental | Drug: XC7 200 mg singleCohort 2 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 200 mg (3 subjects) or placebo (1 subject, see placebo single arm) |
| Placebo single | Placebo comparator | Drug: Placebo singlePlacebo comparator arm will consist of 2 subjects (1 subject from Сohorts 1 and 2) |
| XC7 200 mg multiple | Experimental | Drug: XC7 200 mg multipleCohort 3 - 6 subjects will be randomized in a 6:2 ratio to be treated either XC7 200 mg (6 subjects) or placebo (1 subject, see placebo multiple arm) |
| Placebo multiple | Placebo comparator | Drug: Placebo multiplePlacebo comparator arm will consist of 2 subjects from cohort 3 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking men (nonsmokers at least within the last year before the screening) at the ages from 18 through 45;
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass index from 18.5 to 30.0 kg/m2 with body weight of more than 45 kg and no more than 110 kg;
- Negative result for alcohol vapor content in the exhaled air, narcotic substances in the urine;
- Agreement to use adequate contraception methods during the study and 3 months after its completion: condoms with spermicide (foam, gel, cream, suppository);
Key exclusion criteria (17 listed)
- Chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, musculoskeletal system, as well as the gastrointestinal tract, liver, kidneys, blood, mental illness, epilepsy or convulsive seizures;
- Abnormal results of standard laboratory tests and investigations at the screening visit;
- Gastrointestinal surgery (except for appendectomy) in the past medical history;
- Systolic blood pressure of less than 90 mm Hg or above 139 mm Hg, diastolic blood pressure of less than 60 mm Hg or above 90 mm Hg, heart rate of less than 60 bpm or above 90 bpm - at screening;
- Regular administration of drugs within 2 weeks prior to screening (including herbal agents and dietary supplements);
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 |
|---|---|---|
| XC7 100 mg singleThe volunteers will receive a single dose of the ID (1 capsule once, 100 mg) | Drug | XC7 100 mg single |
| XC7 200 mg singleThe volunteers will receive a single dose of the ID (2 capsules once, 100 mg each) | Drug | XC7 200 mg single |
| Placebo singleThe volunteers will receive a single dose of the ID (1 or 2 capsules once) | Drug | Placebo single |
| XC7 200 mg multipleThe volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each) | Drug | XC7 200 mg multiple |
| Placebo multipleThe volunteers will receive multiple doses of the ID during 14 days (2 capsules daily) | Drug | Placebo multiple |
Primary outcome
Number of Adverse events (AEs) per treatment arm
Time frame: Day -7 (7 days before first dose) - Day 58
Adverse events will be classified according to CTCAE ver 4.03. Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version.
5 secondary outcomes
Pharmacokinetics of XC7 by assessing AUC0-inf
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Cmax
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing AUC0-t
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing Tmax
Time frame: Day 1 - Day 4
Pharmacokinetics of XC7 by assessing T1/2
Time frame: Day 1 - Day 4
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 22 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 XC7 100 mg single, XC7 200 mg single and XC7 200 mg multiple in people with Covid19 and Healthy Volunteers, run by NP Therapeutics at 1 site in Russia.
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 17 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 22 Sep 2021. 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 Russia. 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?
Number of Adverse events (AEs) per treatment arm (time frame: Day -7 (7 days before first dose) - Day 58). 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 22 Sep 2021.