A Clinical Study of TQH2929 in Healthy Adult Subjects

Psoriasis Clinical Trial

Official title:

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156280
• Other study ID #: TQH2929-I-01 (Ia)
• Status: Recruiting
• Phase: Phase 1
• Start date: November 21, 2023
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Hang Li, Doctor
• Phone: 13693058190
• Email: drlihang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is divided into a single dose escalation and a multiple dose escalation phase Ia clinical study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQH2929 injection in healthy adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adults aged between 18 and 55 years old (inclusive), both male and female;

• The male subject should weigh at least 50 kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19~26 kg/m2.

• Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, clinical signs, vital signs, full physical examination, 12-lead Electrocardiogram (ECG), Chest radiograph, abdominal ultrasound and clinical laboratory tests.

• Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content.

• Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 6 months after the last dose (subjects and their partners).

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 evaluated the investigator to be not suitable for the trial;

• People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, Chest radiograph and abdominal ultrasound 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) tests;

• Subjects positive for tuberculoses spot (T-SPOT) result;

• Clinically significant infection requiring antibiotic or antiviral therapy prior to screening and the entire study period;

• Had undergone surgery within 4 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 2 months prior to randomization;

• People who have potential difficulty in blood collection, or have a history of needles or blood sickness;

• Any clear history of drug or food allergies, particularly those with allergies to similar components to the investigational drugs in this trial;

• People who have received or are planning to receive inactivated or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);

• Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products within 6 months prior to randomization, or those who cannot stop using any tobacco-based products during the trial;

• 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 within 3 months prior to screening, or those who cannot refrain from alcohol during the trial, or those 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 biologics within 4 months or 5 half-lives (whichever is longer) prior to randomization;

• Had taken any prescription drugs, over-the-counter drugs, or herbs within 4 weeks prior to randomization, with the exception of vitamin products;

• 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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• TQH2929 injection
TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.
• Placebo injection
Placebo comparator

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE) rate	The occurrence of all adverse events (AE).	Single administration dose (SAD) group: up to Day 113. Multiple administration dose (SAD) group: up tp Day 141.
Primary	Serious adverse events (SAE) rate	The occurrence of all adverse events (SAE).	Single administration dose (SAD) group: up to Day 113. Multiple administration dose (SAD) group: up tp Day 141.
Primary	Treatment-related adverse events (TRAE) rate	The occurrence of all treatment-related adverse events (TRAE).	Single administration dose (SAD) group: up to Day 113. Multiple administration dose (SAD) group: up tp Day 141.
Primary	Incidence of clinical laboratory abnormalities	Proportion of subjects with clinical laboratory abnormalities	Single administration dose (SAD) group: up to Day 113. Multiple administration dose (SAD) group: up tp Day 141.
Secondary	Time to reach maximum observed serum concentration (Tmax), SAD	Time to reach maximum (peak) serum concentration after administration in SAD group	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Time to reach maximum observed serum concentration (Tmax), multiple administration dose (MAD)	Time to reach maximum (peak) serum concentration after administration in MAD group	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Maximum serum concentration (Cmax), SAD	The maximum observed serum concentration of study drug in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Maximum serum concentration (Cmax), MAD	The maximum observed serum concentration of study drug in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Area under the concentration-time curve from zero to infinity (AUC 0-8), SAD	Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Area under the concentration-time curve from zero to infinity (AUC 0-8), MAD	Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Area under the concentration-time curve from 0 to last observation (AUC 0-t), SAD	Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data time-point in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Area under the concentration-time curve from 0 to last observation (AUC 0-t), MAD	Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data time-point in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Apparent volume of distribution (Vd/F), SAD	Apparent volume of distribution of the TQH2929 Injection in serum in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Apparent volume of distribution (Vd/F), MAD	Apparent volume of distribution of the TQH2929 Injection in serum in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Apparent clearance (CL/F), SAD	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body, in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Apparent clearance (CL/F), MAD	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body, in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Half-life (t1/2), SAD	The time required for half of the drug to be eliminated from the serum in SAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Secondary	Half-life (t1/2), MAD	The time required for half of the drug to be eliminated from the serum, in MAD group.	1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Time to maximum plasma concentration at steady state (Tmax, ss)	Time to reach the peak plasma concentration at steady state for TQH2929 Injection.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Maximum concentration of drug in plasma at steady state (Cmax, ss)	The peak plasma concentration of TQH2929 Injection during dosing interval at steady state.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Minimum concentration of drug in plasma at steady state (Cmax, ss)	The minimum plasma concentration at steady state.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Average Plasma Concentration at Steady State (Cav,ss)	Cav,ss is the average plasma concentration at steady state.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Area under curve of steady state (AUCss)	Area under the concentration-time curve of TQH2929 at steady state.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Accumulation ratio (Rac)	Rac is a reflection of how much drug is being added to the body relative to how much is being eliminated from the body during a defined period of time.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Degree of fluctuation (DF)	Degree of fluctuation (DF) of repeated using TQH2929 Injection in healthy adults.	MAD group: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168 hours after injection on Day 1 and Day 29; 1 hour pre-dose on Day 15; 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2352, 2688 hours after dose on Day 29.
Secondary	Anti-drug antibodies (ADA)	Proportion of subjects with a positive ADA reading at any time point during the study.	SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113. MAD group: 1 hour before the first, second and third dose, post-dose on Day 57, Day 85, Day 113, Day 114.