🏛️ Verified NIH Record • Updated 2026-06-04

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus (NCT05835986)

An Open-label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants With Systemic Lupus Erythematosus

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Clinica De La Costa — Barranquilla

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (23 Sites)

  • Clinica De La Costa — Barranquilla,
  • Hospital Pablo Tobon Uribe — Medellín,
  • Oncomedica S.A. — Montería,
  • Hôpital Saint Eloi — Montpellier,
  • Groupe Hospitalier Pitie-Salpetriere — Paris,
  • Charité Research Organisation GmbH — Berlin,
  • Universitätsklinikum Duesseldorf — Düsseldorf,
  • Hospital Umum Sarawak — Kuching,
  • CREA Hospital Mexico Americano — Guadalajara, Jalisco
  • Hospital Angeles De Lindavista — Mexico City, Mexico CITY (federal District)
  • Hospital General De Mexico — Mexico City, Mexico CITY (federal District)
  • Centre For Human Drug Research — Leiden,
  • Clínica San Juan Bautista CSJB — Lima,
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Późna,
  • Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy — Warsaw,
  • FARMOVS (Pty) Ltd — Bloemfontein,
  • Hospital Universitario Reina Sofia — Córdoba,
  • Hospital General Universitario Gregorio Marañon — Madrid,
  • Hospital Universitario 12 de Octubre — Madrid,
  • Chung Shan Medical University Hospital — Taichung,
  • Chang Gung Medical Foundation - Linkou — Taoyuan,
  • Ramathibodi Hospital, Mahidol Uni — Bangkok,
  • UCL Hospital NHS Trust — London,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗