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

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 4, 2020

Primary Completion Date

February 27, 2021

Study Completion Date

March 9, 2022

Conditions
SmallpoxMonkeypoxCowpoxVaccinia 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.

Trial Locations (1)

630559

Federal State Budgetary Healthcare Institution - Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency (FGBUZ MSCH-163, FMBA Russia), Novosibirsk

All Listed Sponsors
lead

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

OTHER_GOV

NCT05976100 - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years | Biotech Hunter | Biotech Hunter