Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Biological: RO7049665

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03221179

WP39826

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated. This trial plans to evaluate approximately seven single dose-levels of RO7049665 or matching-placebo during dose-escalation in approximately 40 participants.

Enrollment

49 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male healthy volunteers, 18 to 45 years of age, inclusive;
Absence of evidence of any active or chronic disease;
Body mass index (BMI) of 18-30 kilograms per square meter (kg/m^2), inclusive;
Contraception requirements: refrain from heterosexual intercourse or use contraceptive measures, and agreement to refrain from donating sperm.

Exclusion criteria

History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis;
Clinically significant abnormalities (as judged by the Investigator) in laboratory test results;
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study;
History of hypersensitivity to biologic agents or any of the excipients in the formulation;
Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection;
Prior administration of aldesleukin, or interleukin-2 (IL-2) derivatives.