A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects

A Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects

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 Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: TQH2722 injection; Drug: Placebo to match TQH2722

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Cao, Doctor; Phone Number: 0532-82917310; Email: caoyu1767@126.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Yu Cao, Doctor; Phone Number: 0532-82917310; Email: caoyu1767@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1 The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions.
• 2 Aged 18 ~ 60 years old (including the critical value), both male and female;
• 3 ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2)
• 4 The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study;
• 5 The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential;
• 6 Normal physical examination, vital signs or abnormal physical examination, vital signs without clinical significance

Exclusion Criteria:

• 1 Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening;
• 2 Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
• 3 People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period;
• 4 Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
• 5 Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization;
• 6 People who received surgical operation within 4 weeks prior to screening, or planned to receive surgical operation during the study period;
• 7 People who participated in other clinical trials and took the study drug within 3 months before screening;
• 8 Received immunoglobulins or blood products within 30 days prior to randomization;
• 9 Blood loss or blood donation of more than 400 mL within 2 months prior to randomization;
• 10 People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness;
• 11 A history of allergic reactions to another therapeutic monoclonal antibody or biologic agent therapy, or any clear history of drug or food allergies, particularly those with allergies to similar components to the drug in this trial;
• 12 People who have received or are planning to receive live-reduced or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);
• 13 Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 6 months prior to randomization and the entire study period (including the follow-up period);
• 14 People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening and the entire study period (including the follow-up period), or those who tested positive for alcohol breath;
• 15 People with a history of substance abuse or positive urine drug screening;
• 16 Received any marketed or research biologics within 4 months or 5 half-lives (whichever is longer) prior to randomization;
• 17 Taking any prescription, over-the-counter and herbal medicines within 4 weeks prior to randomization, with the exception of vitamin products;
• 18 Use of any systemic cytotoxicity or systemic immunosuppressants within 6 months prior to randomization or during the study period, or any local cytotoxin or local immunosuppressive drug within 30 days or 5 half-life periods (whichever is longer) prior to randomization or during the study period;

• 19 Parasitic infection is associated and is excluded if any of the following are met:

  • During the screening period, the stool routinely checks positive for eggs;
  • History of parasitic infection within 6 months prior to the screening period;
  • Have traveled or planned to travel to endemic parasitic infection areas (including but not limited to Southeast and South-West Asia, South America and Africa) within 6 months prior to screening visits;
• 20 Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQH2722 injection; Participants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.	Drug: TQH2722 injection; 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.
Placebo Comparator: Placebo to match TQH2722; Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.	Drug: Placebo to match TQH2722; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AE)	Incidence and severity of adverse events (AE) .	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).	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.	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.	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.	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.	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	From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Pulse	Abnormal values of blood pulse.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration（Cmax）	Maximum Concentration	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	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	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	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	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	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	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	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	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	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	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	Before administration,0.5,1,3,6 hours after administration.

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: TQH2722-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No