NCT05628116 is a Phase 1 clinical trial of XC243 50 mg single in Healthy Volunteers, sponsored by PHARMENTERPRISES LLC.

Who is sponsoring NCT05628116?

NCT05628116 is sponsored by PHARMENTERPRISES LLC.

What drugs are being tested in NCT05628116?

Interventions in NCT05628116: XC243 50 mg single, XC243 100 mg single, Placebo single, XC243 200 mg single-dose food effect, Placebo single-dose food effect, XC243 200 mg multiple, Placebo multiple.

What condition does NCT05628116 study?

NCT05628116 studies Healthy Volunteers.

Is NCT05628116 still recruiting?

NCT05628116 is currently completed. Last updated 18 November 2023.

Last reviewed 2023-11-18 · How we verify

NCT05628116

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Doses of XC243 After Single and Multiple Oral Administration in Healthy Volunteers.

Completed Phase 1 Last updated 18 November 2023

What this trial tests

Phase 1 trial testing XC243 50 mg single in Healthy Volunteers in 38 participants. Completed in 21 September 2023.

Timeline

28 September 2022

Primary endpoint
21 September 2023

21 September 2023

Quick facts

Lead sponsor	PHARMENTERPRISES LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	28 September 2022
Primary completion	21 September 2023
Estimated completion	21 September 2023
Sites	1 location across Russia

Drugs / interventions tested

XC243 50 mg single — full drug profile →
XC243 100 mg single — full drug profile →
Placebo single
XC243 200 mg single-dose food effect — full drug profile →
Placebo single-dose food effect — full drug profile →
XC243 200 mg multiple — full drug profile →
Placebo multiple

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

PHARMENTERPRISES LLC — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC243 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 7 volunteers who will receive a single dose of XC243 (50 mg and 100 mg) or placebo (cohort ratio 5:2), 1 cohort of 14 volunteers who will receive a single dose of XC243 200 mg or placebo first on an empty stomach, and after the washing period after eating (cohort ratio 12:2) and 1 cohort of 10 volunteers who will receive XC243 200 mg or placebo on an empty stomach during 14 days (cohort ratio 8:2).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other PHARMENTERPRISES LLC trials

Trials by the same sponsor.

NCT04527354 — Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia · Phase 2 · completed
NCT03830905 — Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI · Phase 2 · completed
NCT03455491 — Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections · Phase 2 · completed
NCT03459391 — Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers · Phase 1 · completed
NCT03450434 — XC8 in the Treatment of Patients With Bronchial Asthma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05628116 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PHARMENTERPRISES LLC
Last refreshed: 18 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05628116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing