NCT05576012

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Lipum AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	SOL-116	Participants will receive SC injection in a double-blind manner
BIOLOGICAL	Placebo	Participants will receive SC injection in a double-blind manner

Timeline

• Start date: 2022-10-13
• Primary completion: 2024-11-28
• Completion: 2024-11-28
• First posted: 2022-10-12
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

2 sites across 1 country: Netherlands