A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Sponsor
Hoffmann-La Roche
Study ID
NCT05835986
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7507062 — DRUG
    RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
  • Tocilizumab — DRUG
    When applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Study Details

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.

Key Dates

Start date
Dec 18, 2023
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: SAD: RO7507062
    Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1.
  • Experimental: Part 2: Dose Escalation with Fractionated Dosing: RO7507062
    Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days.

Primary Outcome Measure

Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs) [ Time Frame: Day 1 through Day 29 ]

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