Study to Assess Safety, Tolerability and Pharmacokinetics of XC7 (Which is Planned Use in the Treatment of COVID-19) in Healthy Volunteers

NCT04679493 | Completed Phase 1 DMC

• 1 other identifier: COVID-XC7-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Covid19; Healthy Volunteers

Keywords

Coronavirus; Phase I

Outcome Measures

Primary Outcomes (1)

• 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.

  Day -7 (7 days before first dose) - Day 58

Secondary Outcomes (5)

• Pharmacokinetics of XC7 by assessing AUC0-inf

  Day 1 - Day 4

• Pharmacokinetics of XC7 by assessing Cmax

  Day 1 - Day 4

• Pharmacokinetics of XC7 by assessing AUC0-t

  Day 1 - Day 4

• Pharmacokinetics of XC7 by assessing Tmax

  Day 1 - Day 4

• Pharmacokinetics of XC7 by assessing T1/2

  Day 1 - Day 4

Study Arms (5)

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)

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)

Drug: XC7 200 mg single

Placebo single

PLACEBO COMPARATOR

Placebo comparator arm will consist of 2 subjects (1 subject from Сohorts 1 and 2)

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)

Drug: XC7 200 mg multiple

Placebo multiple

PLACEBO COMPARATOR

Placebo comparator arm will consist of 2 subjects from cohort 3

Drug: Placebo multiple

Interventions

XC7 100 mg single DRUG

The volunteers will receive a single dose of the ID (1 capsule once, 100 mg)

XC7 100 mg single

XC7 200 mg single DRUG

The volunteers will receive a single dose of the ID (2 capsules once, 100 mg each)

XC7 200 mg single

Placebo single DRUG

The volunteers will receive a single dose of the ID (1 or 2 capsules once)

Placebo single

XC7 200 mg multiple DRUG

The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each)

XC7 200 mg multiple

Placebo multiple DRUG

The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)

Placebo multiple

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• NP Therapeutics: lead

Study Sites (1)

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, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Single Person

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding was carried out by using placebo equivalent to XC7 capsules without active pharmaceutical ingredients (API) and the corresponding labeling of the ID.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 22, 2020
• Study Start: December 17, 2020
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)