CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Modufolin (arfolitixorin)drug
Likely dose
Modufolin 100 mg injected (single ascending doses)AI-extracted
Key inclusion· 3
  • ✓Healthy male aged 18–60 years inclusive
  • ✓BMI ≥18 and ≤30 kg/m² with weight 50–100 kg and body surface area ≤2 m²
  • ✓Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at screening
Key exclusion· 15
  • ✕History of clinically significant disease or disorder that may put subject at risk or influence results
  • ✕Any clinically significant illness, medical/surgical procedure or trauma within four weeks of first dose
  • ✕Planned major surgery during study duration
  • ✕Positive screening for hepatitis B surface antigen, hepatitis C antibody, or HIV

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

Search/NCT03203564
NCT03203564Phase 1Completed
CompareCT.gov

An Adaptive, Randomized, Double-blind, Single-center, Placebo-controlled Phase I Study Evaluating ECG Effects, Safety and Pharmacokinetics of Single Ascending Doses of [6R]-5,10-Methylene Tetrahydrofolate (Modufolin® for Injection, 100mg) in Healthy Male Volunteers

Isofol Medical AB·interventional·Posted Jun 29, 2017·Updated Sep 25, 2020

In Brief

A Phase 1 clinical trial evaluating Modufolin (arfolitixorin) for Phase I Study in Healthy Volunteers to Evaluate ECG Effect. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluating ECG effects, safety, tolerability and pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhase I Study in Healthy Volunteers to Evaluate ECG Effect
CountriesSweden
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 29, 2017
Enrollment StartJul 4, 2017
Primary CompletionAug 25, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.0 years ago

Interventions

Modufolin (arfolitixorin)drug

Thirty-three eligible and consenting subjects will be included in 3 cohorts, 11 subjects in each cohort, Within each cohort, subjects will be randomized to receive either placebo (3 subjects) or Modufolin® for injection, 100mg (8 subjects)