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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Ia:QLS2404 very low dose
Druga single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 low dose
Druga single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 middle dose
Druga single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 high dose
Druga single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 Max dose
Druga single subcutaneous dose of QLS2404 Injection in healthy participants
Ib:QLS2404 low dose
Drugmultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 middle dose
Drugmultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 high dose
Drugmultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Treatment groups
64 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Ia treatment group 1Experimental treatment 1 intervention
Group B: Ia treatment group 2Experimental treatment 1 intervention
Group C: Ia treatment group 3Experimental treatment 1 intervention
Group D: Ia treatment group 4Experimental treatment 1 intervention
Group E: Ia treatment group 5Experimental treatment 1 intervention
Group F: Ib treatment group 1Experimental treatment 1 intervention
Group G: Ib treatment group 2Experimental treatment 1 intervention
Group H: Ib treatment group 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants
Number of participants with Adverse events and Serious adverse events
Time frame
from the first single subcutaneous Inject of QLS2404 up to Day852
Ib:To evaluate the Adverse events of multiple subcutaneous injections of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS).
Number of participants with Adverse events and Serious adverse events
Time frame
from the first single subcutaneous Inject of QLS2404 up to Day141.Secondary outcomes
1
Ia Outcome 1:To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
include serum QLS2404 concentrations such as peak plasma concentration (Cmax)
Time frame
from the first single subcutaneous Inject of QLS2404 up to Day852
Ia Outcome 2:To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
assessments include serum levels of IgM, IgG, and IgA at each scheduled time point before and after dosing
Time frame
from the first single subcutaneous Inject of QLS2404 up to Day85.3
Ia Outcome 3:To evaluate the immunogenicity of a single subcutaneous injection of QLS2404 Injection in healthy participants.
include the incidence and titers of anti-drug antibodies (ADAs) against QLS2404 Injection in healthy participants, and the incidence of neutralizing antibodies (NAbs), if data permit.
Time frame
from the first single subcutaneous Inject of QLS2404 up to Day854
Ib Outcome 1:Applicable to participants with SLE: The proportion of participants with a ≥ 4-point decrease from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K).
SLEDAI-2K Description: The minimum SLEDAI-2K score is 0, and the maximum theoretical SLEDAI-2K score is 105. A score of 0 indicates no active disease; a greater score indicates higher systemic lupus erythematosus disease activity.
Time frame
from the first subcutaneous Inject of QLS2404 up to Day141.Sponsors and contacts
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Source ClinicalTrials.gov
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