MAD Study of IA-14069 (NCT05533372) | Clinical Trial Compass
RecruitingPhase 1
MAD Study of IA-14069
United States75 participantsStarted 2022-10-10
Plain-language summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA-14069 in healthy subjects and in patients with RA on stable dosese of MTX, with preliminary assessment of efficacy in RA patients.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Sex : Males or females; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
✓. Age : 18 to 55 years, inclusive, for healthy subjects in Part 1 and 18 to 70 years, inclusive, for RA patients in Part 2, at screening.
✓. Body mass index (BMI) : 18 to 32 kg/m2, inclusive, for healthy subjects in Part 1 and 18 to 40 kg/m2, inclusive, for RA patients in Part 2, at screening.
✓. Weight : ≥ 50 kg, inclusive, at screening.
✓. Status : Healthy subjects for Part 1 and RA patients for Part 2.
✓. At screening, females must not be pregnant or lactating.
✓. At screening, females may be of nonchildbearing potential, either surgically sterilized, physiologically incapable of becoming pregnant, or postmenopausal.
✓. Female subjects/patients of childbearing potential who have a fertile male sexual partner (ie, not surgically sterilized for at least 6 months prior to screening) must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of study drug.
Exclusion criteria
✕. Previous participation in the SAD study (Study IA-14069\_1a).
✕. Employee of ICON or the Sponsor.
✕. Use of any investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) prior to admission.
✕. Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the subjects or patients.
✕. Females who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug.
✕. Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last dosing of study drug.
✕. History of relevant drug sensitivity, and/or food allergies, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
✕. Allergy or hypersensitivity to active ingredient or excipients.