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

NCT03221179 | Completed Phase 1

• 1 other identifier: WP39826
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events

  An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  From baseline up to approximately 8 weeks

Secondary Outcomes (10)

• PK: Time to Maximum Concentration (Tmax) of RO7049665

  Pre-dose on Day 1, post-dose on Day 1 at 2 hours (h), 6 h and 12 h, once daily on Days 2-8, Day 12, Day 15, Day 21, Day 29 and Day 43

• PK: Maximum Serum Concentration Observed (Cmax) of RO7049665

  Pre-dose on Day 1, post-dose on Day 1 at 2 hours (h), 6 h and 12 h, once daily on Days 2-8, Day 12, Day 15, Day 21, Day 29 and Day 43

• PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of Last Sampling of RO7049665

  Pre-dose on Day 1, post-dose on Day 1 at 2 hours (h), 6 h and 12 h, once daily on Days 2-8, Day 12, Day 15, Day 21, Day 29 and Day 43

• PK: AUC from Time 0 to infinity (AUCinf) of RO7049665

  Pre-dose on Day 1, post-dose on Day 1 at 2 hours (h), 6 h and 12 h, once daily on Days 2-8, Day 12, Day 15, Day 21, Day 29 and Day 43

• PK: AUC from Time 0 to Time tau (AUC0-t) of RO7049665

  Pre-dose on Day 1, post-dose on Day 1 at 2 hours (h), 6 h and 12 h, once daily on Days 2-8, Day 12, Day 15, Day 21, Day 29 and Day 43

Study Arms (2)

RO7049665

EXPERIMENTAL

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

Biological: RO7049665

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

RO7049665 BIOLOGICAL

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

RO7049665

Placebo BIOLOGICAL

Matching placebo will be administered SC once.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

PRA Health Sciences Early Development Services

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 18, 2017
• Study Start: July 10, 2017
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

NL (1)