CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 90 enrolled
Drug / intervention
NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally +5 moredrug
Likely dose
NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orallyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05976100
NCT05976100Phase 1Completed
CompareCT.gov

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

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"·interventional·Posted Aug 4, 2023·Updated Aug 4, 2023

In Brief

A Phase 1 clinical trial evaluating 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), and 4 other interventions for Smallpox and 3 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
CountriesRussia
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 4, 2023
Enrollment StartSep 4, 2020
Primary CompletionFeb 27, 2021
Study CompletionMar 9, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago

Interventions

NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orallydrug

Volunteers take 1 capsule (200 mg) of NIOCH-14 as a single oral dose.

NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day)drug

Volunteers take 3 capsules (200 mg each) of NIOCH-14 as a single oral dose. (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)drug

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).

NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 a day orally for 6 daysdrug

Volunteers take 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)drug

Volunteers take 3 capsules (200 mg each) of NIOCH-14 a day orally 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)drug

Volunteers take 3 capsules (200 mg each) of NIOCH-14 twice a day orally for 6 days.