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

NCT05576012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-08

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • QPS Netherlands B.V.

    collaborator INDUSTRY

  • Lipum AB

    lead INDUSTRY

Principal Investigators

  • Khalid Abd-Elaziz, MD · QPS Netherlands B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576012 on ClinicalTrials.gov