First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts

Phase 1 Completed 56 enrolled Lipum AB QPS Netherlands B.V. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a multiple dose part in healthy subjects (Part 3). The study will collect information on pharmacokinetics, safety and tolerability.

Timeline

Start: 2022-10-13
Primary completion: 2024-11-28
Completion: 2024-11-28

Publications

Meijs AC, Kolmert J, Lindquist S, Hovstadius P, Grievink HW, Hallgren A, Wennerholm A, Klarenbeek NB, Hernell O. 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. 2026 Jun 22;12(2):e006712. doi: 10.1136/rmdopen-2026-006712.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SOL-116	Monoclonal antibody	0.075 mg/kg	Subcutaneous
Subject	SOL-116	Monoclonal antibody	2.025 mg/kg	Subcutaneous
Subject	SOL-116	Monoclonal antibody	3 mg/kg	Subcutaneous
Subject	SOL-116	Monoclonal antibody	6.075 mg/kg	Subcutaneous

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts

Summary

Timeline

Publications

Drugs

Indications