At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
SOL-116 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SOL-116 and Placebo for Rheumatoid Arthritis. Completed, enrolled 56 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesNetherlands
CollaboratorsQPS Netherlands B.V.
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartOct 2022
Primary CompletionNov 2024
TodayJul 2026
First PostedOct 12, 2022
Enrollment StartOct 13, 2022
Primary CompletionNov 28, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.7 years ago
Interventions
SOL-116biological
Participants will receive SC injection in a double-blind manner
Placebobiological
Participants will receive SC injection in a double-blind manner