NCT05976100

Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years

An Open, Simple, Randomized Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years in Parallel Groups

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smallpox
• Monkeypox
• Cowpox
• Vaccinia Virus Infection

Interventions

Type	Name	Description
DRUG	NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally	Volunteers take 1 capsule (200 mg) of NIOCH-14 as a single oral dose.
DRUG	NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day)	Volunteers take 3 capsules (200 mg each) of NIOCH-14 as a single oral dose. (Total 600 mg NIOCH-14 per day)
DRUG	NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 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).
DRUG	NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days	Volunteers take 1 capsule (200 mg) of NIOCH-14 a day orally for 6 days.
DRUG	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)	Volunteers take 3 capsules (200 mg each) of NIOCH-14 a day orally for 6 days.
DRUG	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)	Volunteers take 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days.

Timeline

• Start date: 2020-09-04
• Primary completion: 2021-02-27
• Completion: 2022-03-09
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: Russia