Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
Condition: Smallpox; Monkeypox; Cowpox; Vaccinia Virus Infection
MeSH terms: Vaccinia; Smallpox; Monkeypox
Study type: Interventional
Phase: Phase 1

Summary: 
      The Aim:

      To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using
      a set of clinical and laboratory-instrumental methods.

      The research tasks are to:

        -  to assess the safety and tolerability of different single doses of the drug;

        -  to assess the safety and tolerability of different repeated doses of the drug;

        -  to study pharmacokinetics of single and repeated administration of the drug;

        -  to assess the data on safety and tolerability to select the optimal drug dosing schedule
           to resolve the issue of conducting phase II clinical trial in an expanded cohort of
           volunteers.
    

Detailed description: 
      An open, simple, randomized study of the safety, tolerability, and pharmacokinetics of
      NIOCH-14 in volunteers aged 18-50 years in parallel groups will be conducted.

      The study included 90 healthy volunteers of both sexes aged 18-50 years who met the inclusion
      criteria, had no exclusion criteria and underwent all screening procedures.

      Grouping of the volunteers:

      1) For a single dose of the drug, three groups will be formed: group 1 - 15 volunteers,
      single 200-mg oral dose; group 2 - 15 volunteers, single 600-mg oral dose; group 3 - 15
      volunteers, single 1200-mg oral dose. Before drug administration, volunteers should be
      hospitalized for a day in the hospital of Federal State Budgetary Healthcare Institution
      "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ
      MSCH-163, FMBA Russia).

      The drug will be first given to 5 healthy volunteers in Group 1. The volunteers will be
      followed up daily by a clinical investigator for 7 days. In the absence of changes in
      clinical analyzes and adverse events and the approval of the findings by the IDMC, the
      remaining subjects in Group 1 will begin to receive the drug.

      After 7 days of the follow-up, the first 5 volunteers in Group 2 (600 mg) will start
      receiving the drug. After 7 days, the remaining 10 volunteers in Group 2 will receive the
      drug.

      The first 5 volunteers in Group 3 will start receiving the drug after obtaining the results
      for the volunteers in Group 2.

      If the volunteers feel satisfactory, they will be discharged on the 2nd day, and then will
      have to visit the clinical site for examination and identification of adverse events daily
      for 7 days, after which all volunteers will be given self- monitoring diaries for
      self-completion to record all adverse events. The volunteers have to present for examination
      and clinical testing on the 10th, 20th, 30th and 90th day after receiving the drug.
    

Intervention name(s): NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally; NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day); NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day); NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days; NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days. (Total 600 mg NIOCH-14 per day for 6 days); NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days. (Total 1200 mg NIOCH-14 per day for 6 days)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Volunteers take 1 capsule (200 mg) of NIOCH-14 as a single oral dose.; Volunteers take 3 capsules (200 mg each) of NIOCH-14 as a single oral dose. (Total 600 mg NIOCH-14 per day); Single 1200-mg oral dose. (1200-mg dose of the drug is administered by 600 mg twice a day at 8-00 and 20-00 in the hospital and presence of a clinical investigator or a nurse).; Volunteers take 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days.; Volunteers take 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days.; Volunteers take 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days.
Other intervention name(s): 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule; 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule; 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule; 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule; 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule; 7-[N-(4-trifluoromethylbenzoyl)-hydrazinocarbonyl]-tricyclo-[3.2.2.02,4]non-8-en-6-carboxylic acid, 200 mg capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Оrthopoxviruses; Smallpox; NIOCH-14; Сlinical study