RecruitingPhase 1

Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

Russia36 participantsStarted 2025-01-13

Plain-language summary

This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent form by the healthy subject prior to any study activities.
. Males and females aged 18 to 45 years (inclusive) of Caucasian race.
. Verified "healthy" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).
. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).
. Heart rate (HR) from 60 to 89 beats per minute (inclusive).
. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).
. Body temperature from 36.0°C to 36.9°C (inclusive).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics - Cmax

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - tmax

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - AUC0-t

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - AUC0-inf

Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

Pharmacokinetics - AUCextr

Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

Pharmacokinetics - t1/2

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - kel

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Trial details

NCT IDNCT06859333

SponsorValenta Pharm JSC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Influenza trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed informed consent form by the healthy subject prior to any study activities.
. Males and females aged 18 to 45 years (inclusive) of Caucasian race.
. Verified "healthy" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).
. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).
. Heart rate (HR) from 60 to 89 beats per minute (inclusive).
. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).
. Body temperature from 36.0°C to 36.9°C (inclusive).

What they're measuring

Pharmacokinetics - Cmax

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - tmax

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - AUC0-t

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - AUC0-inf

Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

Pharmacokinetics - AUCextr

Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

Pharmacokinetics - t1/2

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Pharmacokinetics - kel

Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria