A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.
Eligibility criteria
Qualifiers
Ia
Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.
Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.
Body mass index (BMI) at screening ≥19 kg/m² and ≤26 kg/m², with body weight ≥45 kg.
Disqualifiers
Ia
QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.
Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.
Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.
Trial design
Treatments tested in this trial
- Ia:QLS2404 very low dose
- Ia:QLS2404 low dose
- Ia:QLS2404 middle dose
- Ia:QLS2404 high dose
- Ia:QLS2404 Max dose
- Ib:QLS2404 low dose
- Ib:QLS2404 middle dose
- Ib:QLS2404 high dose
Treatment groups
64 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov