A Clinical Trial of TQC2938 Injection in Healthy Adult Subjects

NCT06449859 | Unknown Phase 1

• 1 other identifier: TQC2938-I-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Maximum serum concentration (Cmax) of subcutaneous injection for single dose

  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

  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

  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

  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

  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

Study Arms (10)

TQC2938 Injection (52.5mg/0.35ml)

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of subcutaneous (SC) injection.

Drug: TQC2938 Injection

TQC2938 Injection (210mg/1.4ml)-subcutaneous injection

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of subcutaneous injection.

Drug: TQC2938 Injection

TQC2938 Injection (210mg/1.4ml)-intravenous injection

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of intravenous (IV) injection .

Drug: TQC2938 Injection

TQC2938 Injection (420mg/2.8ml)

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of subcutaneous injection.

Drug: TQC2938 Injection

TQC2938 Injection (840mg/5.6ml)-subcutaneous injection

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of subcutaneous injection.

Drug: TQC2938 Injection

TQC2938 Injection (1260mg/8.4ml)

EXPERIMENTAL

TQC2938 Injection is administered as a single dose of subcutaneous injection.

Drug: TQC2938 Injection

TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses

EXPERIMENTAL

TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.

Drug: TQC2938 Injection

TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses

EXPERIMENTAL

TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.

Drug: TQC2938 Injection

TQC2938 Injection (630mg/4.2ml)

EXPERIMENTAL

TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total.

Drug: TQC2938 Injection

TQC2938 Placebo

PLACEBO COMPARATOR

TQC2938 Placebo is administered as a single dose or multiple doses, once every 28 days, three times in total.

Drug: TQC2938 Placebo

Interventions

TQC2938 Injection DRUG

TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade.

TQC2938 Injection (1260mg/8.4ml); TQC2938 Injection (210mg/1.4ml)-intravenous injection; TQC2938 Injection (210mg/1.4ml)-subcutaneous injection; TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses; TQC2938 Injection (420mg/2.8ml); TQC2938 Injection (52.5mg/0.35ml); TQC2938 Injection (630mg/4.2ml); TQC2938 Injection (840mg/5.6ml)-subcutaneous injection; TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses

TQC2938 Placebo DRUG

TQC2938 Placebo is a placebo comparator

TQC2938 Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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。

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 10, 2024
• Study Start: June 13, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-01

Locations

CN (1)