CompletedNCT06156280Updated Mar 25, 2025

A Clinical Study of TQH2929 in Healthy Adult Subjects

A Phase 1 interventional study of TQH2929 injection and Placebo injection in Psoriasis, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Psoriasis

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Psoriasis 1,899

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. is the lead sponsor of 53 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Experimental
TQH2929 Injection (1 mg/kg)
TQH2929 Injection 1 mg/kg is administered as a single dose.
Drug: TQH2929 injection
Experimental
TQH2929 Injection (3 mg/kg)
TQH2929 Injection 3 mg/kg is administered as a single dose.
Drug: TQH2929 injection
Experimental
TQH2929 Injection (10 mg/kg)
TQH2929 Injection 10 mg/kg is administered as a single dose.
Drug: TQH2929 injection
Experimental
TQH2929 Injection (20 mg/kg)
TQH2929 Injection 20 mg/kg is administered as a single dose.
Drug: TQH2929 injection
Experimental
TQH2929 Injection (30 mg/kg)
TQH2929 Injection 30 mg/kg is administered as a single dose.
Drug: TQH2929 injection
Placebo comparator
Placebo Injection
Placebo injection is administered as a single dose or multiple doses (once every two weeks).
Drug: Placebo injection

Interventions

DrugTQH2929 injection
TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.
DrugPlacebo injection
Placebo comparator

What researchers measure

Primary outcomes

Adverse events (AE) rate
The occurrence of all adverse events (AE).
Time frame: Single dose: Up to Day 113
Serious adverse events (SAE) rate
The occurrence of all adverse events (SAE).
Time frame: Single dose: Up to Day 113
Treatment-related adverse events (TRAE) rate
The occurrence of all treatment-related adverse events (TRAE).
Time frame: Single dose: Up to Day 113
Incidence of clinical laboratory abnormalities
Proportion of subjects with clinical laboratory abnormalities
Time frame: Single administration dose (SAD) group: up to Day 113

Secondary outcomes

Time to reach maximum observed serum concentration (Tmax), SAD
Time to reach maximum (peak) serum concentration after administration in SAD group
Time frame: 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.
Maximum serum concentration (Cmax), SAD
The maximum observed serum concentration of study drug in SAD group.
Time frame: 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.
Area under the concentration-time curve from zero to infinity (AUC 0-∞), 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.
Time frame: 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.
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.
Time frame: 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.
Apparent volume of distribution (Vd/F), SAD
Apparent volume of distribution of the TQH2929 Injection in serum in SAD group.
Time frame: 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.
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.
Time frame: 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.
Half-life (t1/2), SAD
The time required for half of the drug to be eliminated from the serum in SAD group.
Time frame: 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.
Anti-drug antibodies (ADA)
Proportion of subjects with a positive ADA reading at any time point during the study.
Time frame: SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113.

Study locations

1 site

Peking University First Hospital
Beijing, Beijing 100871, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06156280
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Dec 5, 2023
Start date: Nov 21, 2023
Primary completion: Aug 2, 2024
Completion: Mar 21, 2025
Last update: Mar 25, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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