A Phase 1, Open Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 1\. Healthy subjects with absence of clinically relevant abnormalities as determined by the Investigator or medically qualified designee based on a detailed medical history and complete physical examination;

• 2\. Clinical laboratory test results for liver and renal function within the normal reference range. For all other clinical laboratory parameters, results outside the normal reference range to be confirmed by the Investigator and the Sponsor as not clinically significant;

• 3\. Male or female subjects ≥18 and ≤55 years of age with a minimum body weight of 50 kg and a body mass index of ≥18.0 to ≤30.0 kg/m2 at the time of signing the informed consent form (ICF);

• 4\. Subjects willing and able to comprehend and sign informed consent and to comply with the requirements of this study.

Locations
United States
California
Anaheim Clinical Trials, LLC
RECRUITING
Anaheim
Contact Information
Primary
Katharina Staufer, PD Dr. med.univ, MD
contact@genfit.com
+333 20 16 40 00
Backup
Nathalie Doize
contact@genfit.com
+333 20 16 40 00
Time Frame
Start Date: 2025-08-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 52
Treatments
Experimental: G1090N 300 mg
Subjects will recieve a single dose of G1090N
Experimental: G1090N 600 mg
Subjects will recieve single and multiple doses of G1090N
Experimental: G1090N 900 mg
Subjects will recieve single and multiple doses of G1090N
Experimental: G1090N 1200 mg
Subjects will recieve single and multiple doses of G1090N
Related Therapeutic Areas
Sponsors
Leads: Genfit

This content was sourced from clinicaltrials.gov

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