A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGAdverse events (AE)
Incidence and severity of adverse events (AE) .
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Serious adverse events (SAE)
Incidence and severity of Serious adverse events (SAE).
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood biochemistry
Abnormal indicators of blood biochemistry.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Coagulation function
Abnormal indicators of coagulation function.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood routine
Abnormal indicators of blood routine.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Urinalysis
Abnormal indicators of urinalysis.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Blood pressure
Abnormal values of blood pressure
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pulse
Abnormal values of blood pulse.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Body temperature
Abnormal values of blood body temperature.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Skin
Examination of the skin.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Mucous membranes
Examination of the mucous membranes.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Lymph nodes
Examination of the lymph nodes.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Head
Examination of the head.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Neck
Examination of the neck.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Chest
Examination of the chest.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abdomen
Examination of the abdomen.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Spine
Examination of the spine.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Limbs
Examination of the limbs.
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
12-lead electrocardiogram
Abnormal values of 12-lead electrocardiogram
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Maximum Concentration(Cmax)
Maximum Concentration
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Minimum Concentration(Cmax)
Minimum Concentration
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Time to maximum concentration(Tmax)
Time to maximum concentration following drug administration
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Area under the drug-time curve(AUC)
Area under the drug-time curve
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent terminal elimination half-life(t1/2)
Apparent terminal elimination half-life following drug administration
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Apparent volume of distribution(Vd/F)
Apparent volume of distribution
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Clearance rate(CL/F)
Clearance rate
Time frame: SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose
Immunoglobulin E(IgE)
Percentage of changes in serum IgE
Time frame: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Thymus activation regulates chemokines(TARC)
Percentage of changes in serum TARC
Time frame: SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Anti-drug antibody (ADA)
Incidence and titer of anti-drug antibody
Time frame: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Neutralizing Antibody(Nab)
Incidence of Neutralizing Antibody
Time frame: SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Injection site response
Injection site response assessment
Time frame: Before administration,0.5,1,3,6 hours after administration.