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

NCT05976100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

  • Smallpox
  • Monkeypox
  • Cowpox
  • Vaccinia Virus Infection

Interventions

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.

Sponsors & Collaborators

  • Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

    lead OTHER_GOV

Principal Investigators

  • Vladimir I. Kuzubov, PhD · FGBUZ MSCH-163, FMBA Russia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2021-02-27
Completion
2022-03-09

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976100 on ClinicalTrials.gov