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

NCT05835986 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

RO7507062

RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).

DRUG

Tocilizumab

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Colombia
  • France
  • Germany
  • Malaysia
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05835986 on ClinicalTrials.gov