PsoriasisPhase 1NCT06156280

A Clinical Study of TQH2929 in Healthy Adult Subjects

A Phase 1 study testing TQH2929 injection in people with Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Psoriasis
What is being tested?: TQH2929 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteChina
Study dates: 21 Nov 2023to 21 Mar 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100871

Other trials in China

About this study

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

Conditions: Psoriasis
Being tested: TQH2929 injection, Placebo injection
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06156280
Study group	Role	What they receive
TQH2929 Injection (1 mg/kg)	Experimental	TQH2929 Injection 1 mg/kg is administered as a single dose. Receives: Drug: TQH2929 injection
TQH2929 Injection (3 mg/kg)	Experimental	TQH2929 Injection 3 mg/kg is administered as a single dose. Receives: Drug: TQH2929 injection
TQH2929 Injection (10 mg/kg)	Experimental	TQH2929 Injection 10 mg/kg is administered as a single dose. Receives: Drug: TQH2929 injection
TQH2929 Injection (20 mg/kg)	Experimental	TQH2929 Injection 20 mg/kg is administered as a single dose. Receives: Drug: TQH2929 injection
TQH2929 Injection (30 mg/kg)	Experimental	TQH2929 Injection 30 mg/kg is administered as a single dose. Receives: Drug: TQH2929 injection
Placebo Injection	Placebo comparator	Placebo injection is administered as a single dose or multiple doses (once every two weeks). Receives: Drug: Placebo injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Time to reach maximum observed serum concentration (Tmax), SAD
Time to reach maximum (peak) serum concentration after administration in SAD group
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202321 Mar 2025

First posted5 Dec 2023
Study start21 Nov 2023
Primary completion2 Aug 2024
Study completion21 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06156280
Sponsor's protocol ID: TQH2929-I-01 (Ia)
Status last verified: Mar 2025
First submitted: 27 Nov 2023
Last updated: 25 Mar 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06156280
Acronym / sponsor ID: TQH2929-I-01 (Ia)
Conditions: Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Nov 2023 (actual)
Primary completion: 2 Aug 2024 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 5 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
TQH2929 Injection (1 mg/kg)	Experimental	Drug: TQH2929 injectionTQH2929 Injection 1 mg/kg is administered as a single dose.
TQH2929 Injection (3 mg/kg)	Experimental	Drug: TQH2929 injectionTQH2929 Injection 3 mg/kg is administered as a single dose.
TQH2929 Injection (10 mg/kg)	Experimental	Drug: TQH2929 injectionTQH2929 Injection 10 mg/kg is administered as a single dose.
TQH2929 Injection (20 mg/kg)	Experimental	Drug: TQH2929 injectionTQH2929 Injection 20 mg/kg is administered as a single dose.
TQH2929 Injection (30 mg/kg)	Experimental	Drug: TQH2929 injectionTQH2929 Injection 30 mg/kg is administered as a single dose.
Placebo Injection	Placebo comparator	Drug: Placebo injectionPlacebo injection is administered as a single dose or multiple doses (once every two weeks).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (20 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TQH2929 injectionTQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.	Drug	TQH2929 Injection (1 mg/kg), TQH2929 Injection (10 mg/kg), TQH2929 Injection (20 mg/kg), TQH2929 Injection (3 mg/kg), TQH2929 Injection (30 mg/kg)
Placebo injectionPlacebo comparator	Drug	Placebo Injection

Primary outcome

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

8 secondary outcomes

Time to reach maximum observed serum concentration (Tmax), SAD
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
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
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
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
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
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
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)
Time frame: SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQH2929 injection in people with Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AE) rate (time frame: Single dose: Up to Day 113). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06156280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.