Trial reportRMD open2026
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.
Trial report in RMD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05576012 (A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis), which is not on this map. Not yet cited in PubMed.
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A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis
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Authors and funding
9 authors.
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Abstract
objectiveBile salt-stimulated lipase (BSSL) is a digestive lipolytic enzyme and a potential novel drug target for treatment of rheumatoid arthritis (RA). Here, we report the results of the first-in-human study of SOL-116, a first-in-class humanised IgG4 monoclonal antibody targeting BSSL, conducted in healthy participants and patients with RA.
methodsThis was a randomised, double-blind, placebo-controlled study of ascending single doses (0.075-6.075 mg/kg) and multiple doses (4 doses of 3.0 mg/kg every 4 weeks) of subcutaneously administered SOL-116 in healthy participants, as well as a single dose (2.025 mg/kg) in patients with RA. Safety and tolerability were assessed as the primary objective and pharmacokinetics (PK) and immunogenicity as secondary objectives. Exploratory objectives included evaluating BSSL concentrations and inflammatory markers.
resultsSOL-116 was safe and well tolerated at the tested dose levels in 48 healthy participants and 8 patients with RA. There was a dose-proportional increase in area under the curve and maximum concentration across the single dose cohorts in healthy participants, with comparable PK characteristics between healthy participants and patients with RA and a low frequency of anti-drug antibodies. Notably, SOL-116 effectively reduced free BSSL levels in circulation, confirming target engagement although no clear changes in other exploratory inflammation markers were observed.
conclusionsThis study demonstrated that SOL-116 has a favourable safety and PK profile. Combined with effective reduction of free BSSL in the circulation, findings in this study support ongoing clinical development of SOL-116, with a focus on elucidating the efficacy and mechanism of action of BSSL in the treatment of chronic inflammation, primarily RA. TRIAL REGISTRATION NUMBER: NCT05576012.
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