A Phase 1 interventional study of TQB3702 tablets and TQB3702 placebo in Systemic Lupus Erythematosus, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TQB3702 tables is administered as a single dose or multiple dose.
Drug: TQB3702 tablets
TQB3702 placebo is administered as a single dose or multiple dose.
Drug: TQB3702 placebo
TQB3702 tablets is administered as a single dose on day 1, or once daily on Days 1 to 7 on multiple dose. Dosage: 100mg, 150/200mg.
TQB3702 placebo contains no active substance.
Adverse events rate
Number of subjects with adverse events (AEs) and serious adverse events (SAEs), the evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0).
Time frame: 17 days
Abnormal laboratory test indicators
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Time frame: 17 days
Time to reach maximum observed plasma concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration.
Time frame: 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration of TQB3702.
Time frame: 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose
Elimination half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time frame: 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.