First-in-human (phase I) trial of SOL-116, a humanised IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients
Authors' conclusion
This study demonstrated that SOL-116 has a favourable safety and PK profile.
Study context
- Population
- Healthy participants and patients with rheumatoid arthritis (RA)48 healthy, 8 with RA
- Comparison
- SC SOL-116 vs placebo
- Primary endpoint
- Safety and tolerability
Methodological detailsfirst-in-human, phase I, double-blind, placebo-controlled, single ascending dose, multiple dose
- First-in-human, phase I
- Double-blind
- Placebo-controlled
- Single ascending dose
- Multiple dose
Primary result
As reported in the abstract
- SOL-116 safe and well tolerated at the tested dose levels in healthy participants and patients with RA
Secondary outcomes
Pharmacokinetics (PK): AUC and maximum concentration
- Dose-proportional increase across single dose cohorts in healthy participants; PK comparable between healthy participants and patients with RA
Immunogenicity (anti-drug antibodies)
- Low frequency of anti-drug antibodies
Free circulating bile salt-stimulated lipase (BSSL) (exploratory)
- SOL-116 effectively reduced free BSSL levels, confirming target engagement
Other inflammation markers (exploratory)
- No clear changes observed
Safety
Safety and tolerability
- Safe and well tolerated at the tested dose levels
Original publication
First-in-human (phase I) trial of SOL-116, a humanised IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients. RMD Open. Published 22 June 2026. doi:10.
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