Compare Bioavailability of RO7239361 After Subcutaneous Injection

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: RO7239361

Study type: Interventional

Funder types: Industry

Identifiers

NCT03100630

CN001-023

WP40225 (Other Identifier)

Details and patient eligibility

About

Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.

Enrollment: 99 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
• Body Mass Index 18 kg/m2 to 32 kg/m2
• females must be of non-childbearing potential

Exclusion criteria

• tattoos or other skin findings on any of the potential injection sites
• history of chronic muscle pain within 30 days prior to study treatment
• prior history of IgG1 therapy

Other protocol defined inclusion and exclusion criteria apply

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Treatment A: RO7239361

Active Comparator group

Description:

RO7239361 subcutaneous injections on specified days; abdomen

Treatment:

Drug: RO7239361

Treatment B: RO7239361

Active Comparator group

Description:

RO7239361 subcutaneous injections on specified days; arm

Treatment:

Drug: RO7239361

Treatment C: RO7239361

Active Comparator group

Description:

RO7239361 subcutaneous injections on specified days; thigh

Treatment:

Drug: RO7239361