Status:
COMPLETED
Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers
Lead Sponsor:
PHARMENTERPRISES LLC
Conditions:
Influenza
Acute Respiratory Infection
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of drug XC221 after single and repeated oral administration in healthy volunte...
Detailed Description
One Russian center was approved for participation in this study. One center was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administrat...
Eligibility Criteria
Inclusion
- Non-smoking men aged 18 to 45 years (inclusive);
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass \>50 kg and body mass index of 18.5 to 30 kg/m2 (inclusive);
- Negative result of tests for alcohol and drugs;
- Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);
- Signed patient information sheet and informed consent form for participation in the study.
Exclusion
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system and also disease of digestive tract, liver, kidneys, blood;
- Laboratory abnormalities at screening;
- Surgical interventions on digestive tract in the anamnesis (except for an appendectomies);
- Systolic pressure is less than 90 mm Hg. or more than 130 mm Hg., diastolic pressure is less than 60 mm Hg. or more than 85 mm Hg., pulse rate less than 60/min. or more than 80/min.;
- Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
- Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
- The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
- Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening; smoking 3 months before screening;
- History of allergies (including medicines and food products);
- Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
- Participation in other clinical trials or taking the study drug during 3 months before screening;
- Acute infectious diseases less than 4 weeks before the start of the study;
- Impossibility to understand or follow protocol instructions/
Key Trial Info
Start Date :
May 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03459391
Start Date
May 22 2017
End Date
September 26 2017
Last Update
March 8 2018
Active Locations (1)
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1
SBEI HPE The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation, University Hospital #2, Department of Development of New Medicines
Moscow, Russia, 119435