A Clinical Trial of TQC2938 Injection in Healthy Adult Subjects

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TQC2938 Injection in Healthy Adult Subjects After Single and Multiple Administration

The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: TQC2938 Injection; Drug: TQC2938 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sign informed consent before the study to fully understand the purpose, process and possible adverse reactions of the test.
• Adults aged between 18 and 60 years (inclusive)，both male and female;
• The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 18~28 kg/m2 (inclusive);
• The subjects were able to communicate well with the investigators, voluntarily and were able to understand and follow the protocol to complete the study;
• Female patient had no plans to become pregnant for 6 months from the date of signing the informed consent to the last dose, and must use effective non-drug contraception with their sexual partners of childbearing age。

Exclusion Criteria:

• Pregnant or lactating women;
• Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
• People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG) and Chest radiograph during screening period;
• 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);
• A history of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), occurred within 30 days prior to and during screening and required antibiotic or antiviral treatment;
• Had undergone surgery within 8 weeks prior to screening period or expected to undergo surgery during the study period;
• Participated in any clinical trial within 3 months prior to the screening period;
• Received immunoglobulins or blood products within 30 days prior to randomization;
• Blood donation or significant blood loss of more than 400 mL within 3 months prior to randomization, or plan to donate blood within 3 months;
• Potential blood collection difficulties, can not tolerate venipuncture or have a history of fainting needles and fainting blood;
• A history of allergic reaction to treatment with another therapeutic monoclonal antibody or biologics, a history of any well-defined drug or food allergy, especially to ingredients similar to the drug in this trial;
• Those who received or planned to receive inactivated or active vaccines within 30 days prior to randomization or throughout the study period, including the follow-up period；
• Those who smoked more than 5 cigarettes/day or used a comparable amount of nicotine or nicotine-containing products in the 6 months prior to randomization, or could not stop using any tobacco products during the trial period；
• People with chronic alcohol abuse or who drank more than 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or who could not abstain during the test period, or who tested positive for alcohol breath；
• History of drug abuse or a positive result of urine drug test at screening;
• Received any marketed or investigational biological agent (other than vaccines) within 4 months or 5 half-lives (whichever is older) prior to randomization；
• Any prescription, over-the-counter, and herbal medicines, except vitamin products, were taken in the 4 weeks prior to randomization；
• 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；
• 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

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC2938 Injection (52.5mg/0.35ml); TQC2938 Injection is administered as a single dose of subcutaneous (SC) injection.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (210mg/1.4ml)-subcutaneous injection; TQC2938 Injection is administered as a single dose of subcutaneous injection.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (210mg/1.4ml)-intravenous injection; TQC2938 Injection is administered as a single dose of intravenous (IV) injection .	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (420mg/2.8ml); TQC2938 Injection is administered as a single dose of subcutaneous injection.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (840mg/5.6ml)-subcutaneous injection; TQC2938 Injection is administered as a single dose of subcutaneous injection.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (1260mg/8.4ml); TQC2938 Injection is administered as a single dose of subcutaneous injection.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses; TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses; TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Experimental: TQC2938 Injection (630mg/4.2ml); TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.	Drug: TQC2938 Injection; TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Placebo Comparator: TQC2938 Placebo; TQC2938 Placebo is administered as a single dose or multiple doses, once every 28 days, three times in total.	Drug: TQC2938 Placebo; TQC2938 Placebo is a placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	The occurrence of all adverse events (AEs).	Single dose: Up to Day 113. Multiple doses: Up to Day 169
Serious adverse events (SAEs)	The occurrence and incidence of all serious adverse events (SAEs).	Single dose: Up to Day 113. Multiple doses: Up to Day 169
Clinical laboratory abnormalities	Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram, etc.	Single dose: Up to Day 113. Multiple doses: Up to Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum serum concentration (Cmax) of subcutaneous injection for single dose	The Cmax is the maximum observed serum concentration of study drug.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Maximum serum concentration (Cmax) of intravenous injection for single dose	The Cmax is the maximum observed serum concentration of study drug.	Single dose: pre-dose (-1 to 0 hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Maximum serum concentration (Cmax) of subcutaneous injection for multiple doses	The Cmax is the maximum observed serum concentration of study drug.	Multiple doses: pre-dose (-1 to 0 hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose on multiple dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for single dose	Time to reach maximum (peak) serum concentration following drug administration.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of intravenous injection for single dose	Time to reach maximum (peak) serum concentration following drug administration.	Single dose: pre-dose (-1 to 0hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for multiple doses	Time to reach maximum (peak) serum concentration following drug administration.	Multiple doses: pre-dose (-1 to 0hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504hours post-dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Minimum concentration of drug in serum at steady state (Cmin, ss) of subcutaneous injection for multiple doses	Cmin,ss is the minimum serum concentration at steady state.	Multiple doses: Pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of subcutaneous injection for single dose	Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of intravenous injection for single dose	Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.	Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of of subcutaneous injection for multiple dose	Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.	Multiple doses: pre-dose(-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Maximum concentration of drug in serum at steady state (Cmax, ss) of subcutaneous injection for multiple doses	Cmax, ss is the peak serum concentration of TQC2938 Injection during dosing interval at steady state.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Time to maximum serum concentration at steady state (Tmax, ss) of subcutaneous injection	Tmax,ss is defined as time to reach the peak serum concentration at steady state for TQC2938 Injection.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Area under curve of steady state (AUCss) of subcutaneous injection	To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Half-life (t1/2) of subcutaneous injection for single dose	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Half-life (t1/2) of intravenous injection for single dose	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.	Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Half-life (t1/2) of intravenous injection for multiple dose	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent volume of distribution (Vd/F) of subcutaneous injection for single dose	Apparent volume of distribution of the TQC2938 Injection in serum.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent volume of distribution (Vd/F) of intravenous injection for single dose	Apparent volume of distribution of the TQC2938 Injection in serum.	Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent volume of distribution (Vd/F) of subcutaneous injection for multiple dose	Apparent volume of distribution of the TQC2938 Injection in serum.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Apparent clearance (CL/F) of subcutaneous injection for single dose	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose
Apparent clearance (CL/F) of intravenous injection for single dose	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose
Apparent clearance (CL/F) of subcutaneous injection for multiple dose	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Accumulation ratio (Rac) of subcutaneous injection for multiple dose	To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum.	Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57
Anti-drug antibodies (ADA)	Incidence of ADA, a participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.	Single dose: (-1 to 0 hour) (pre-dose), 672, 1344, 2016 and 2688 hours postdose. Multiple doses: (-1 to 0 hour) before the first,second and third administration, 1344 and 2688 hours after intravenous injection of Day 57

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TQC2938-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