A Two-part, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single Ascending Doses of SAR441121 Including a Pilot Food Evaluation (TDU15302) and its Antimalarial Activity against Plasmodium falciparum Blood Stage Infection (PDY15303) in Healthy Male Subjects.

sanofi-aventis australia ptd ltd0 sites62 target enrollmentOctober 30, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: sanofi-aventis australia ptd ltd
Enrollment: 62
Status: Recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 30, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

sanofi-aventis australia ptd ltd

Eligibility Criteria

Inclusion Criteria

•Male subjects, between 18 and 49 years of age, inclusive.
•Body weight between 50\.0 and 100\.0 kg, inclusive, body mass index between 18\.0 and 32\.0 kg/m2, inclusive.
•Normal vital signs after 5 minutes resting in supine position.
•Normal electrocardiogram parameters after 5 minutes resting in supine position.
•Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.
•Male subject, whose partners are of childbearing potential (including pregnant or lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing.
•Male subject must agree not to donate sperm from the screening up to 3 months after the last dosing.

Exclusion Criteria

•Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
•Presence or history of drug hypersensitivity, or allergic disease diagnosed by an allergist/immunologist and/or treated by a physician for allergy or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion, or subjects with a documented food allergy requiring specific medical management
•History or presence of alcohol abuse (alcohol consumption of more than 40g per day) or drug habituation, or any previous usage of an illicit substance.
•Tobacco use of more than 5 cigarettes or equivalent per day, and unable to stop smoking for the duration of the clinical unit confinement.
•Any medication (including St John’s Wort) within 14 days before consenting or within 5 times the elimination half\-life or pharmacodynamic half\-life of the medication except occasional intakes of ibuprofen at doses up to 1\.2g/day or paracetamol at doses up to 2g/day.
•Participation in any investigational product study within the 12 weeks (counted from the last dose taken) prior to Investigational Medicinal Product (IMP) administration.
•Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 3 months before inclusion.
•Any consumption of grapefruit and Sevilles oranges, etc or their juices within 5 days prior to Investigational Medicinal Product (IMP) administration.
•For the food effect cohort, vegetarian subjects or subjects with lactose intolerance must be excluded.
•History of serious psychiatric condition that may affect participation in the study or preclude compliance with the protocol, including but not limited to past or present psychoses, disorders requiring lithium, a history of attempted or planned suicide, more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.