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

NCT ID: NCT03221179

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2019-07-05

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RO7049665

Participants will be administered a single SC dose of RO7049665 administered in up to 4 SC injection.

Group Type: EXPERIMENTAL

RO7049665

Intervention Type: BIOLOGICAL

A single ascending dose (starting dose 1.5 micrograms \[mcg\])of RO7049665 will be administered SC.

Placebo

Participants will be administered a single SC dose of matching placebo formulation administered in up to 4 SC injections.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Matching placebo will be administered SC once.

Interventions

RO7049665

A single ascending dose (starting dose 1.5 micrograms \[mcg\])of RO7049665 will be administered SC.

Intervention Type: BIOLOGICAL

Placebo

Matching placebo will be administered SC once.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

PRA Health Sciences Early Development Services

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

WP39826

Identifier Type: -

Identifier Source: org_study_id