PsoriasisPhase 1NCT06230588
A Clinical Trial of TQH3906 Capsules in Healthy Volunteers
A Phase 1 study testing TQH3906 capsule in people with Psoriasis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study was divided into three parts: single and multiple dosing and food effect study, which were designed to evaluate the safety and tolerability of TQH3906 capsules administered in single or multiple dose escalation in healthy adult subjects. 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?
- TQH3906 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 27 Apr 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
- Healthy subjects aged 18-55 years (including 18 and 55 years), regardless of gender.
- Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) of 19-26 kg/m2 (included).
- Be in good health with no abnormalities of clinical significance according to medical history, clinical symptoms, vital signs, physical examination, 12-lead electrocardiogram, chest radiographs, abdominal ultrasound, and laboratory tests
- Have a full understanding of the study, participate in the trial voluntarily, and have signed a written informed consent form.
- Subjects (including partners) are willing to voluntarily use appropriate and effective contraception from screening until 3 months after the last dose of study drug.
Who cannot join
- Pregnant, lactating women.
- Previous history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, infectious, hematologic, neurologic, or psychiatric disorders/abnormalities, or related chronic illnesses, or acute illnesses, which the investigator assesses as contraindicated for participation in the trial.
- Have a QTc > 450 ms in males and > 470 ms in females at screening, or whose Electrocardiograph (ECG) is unsuitable for Concentration QT (C-QT) measurement (at the discretion of the investigator).
- The presence of risk factors and history of tip-twist ventricular tachycardia including, but not limited to: unexplained syncope, long QT syndrome, heart failure, or clinically significant abnormal laboratory tests (including hypokalemia, hypercalcemia, or hypomagnesemia) identified at Screening.
- Presence of abnormal serum virology at screening;
- Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) antibody positive;
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- Positive for Human immunodeficiency virus (HIV) antibody at the screening stage, or previous history of HIV infection;
- Positive antibodies to Treponema pallidum in screening.
- Presence of active tuberculosis during the Screening Period, or being a close household contact of a patient with untreated active tuberculosis, or having a positive tuberculosis interferon gamma release assay (TB-IGRA) by laboratory examination.
- A history of severe bacterial, fungal or viral infection requiring hospitalization for intravenous antibiotic or antiviral medication within 2 months prior to randomization.
- Live vaccination within 4 weeks prior to randomization or planning to receive a live vaccine during the study.
- The presence of clinically significant infections during the Screening Period, including but not limited to upper respiratory tract infections, lower respiratory tract infections, herpes simplex, herpes zoster, and requiring treatment with antibiotics or antiviral medications.
- A history of severe herpes zoster or herpes simplex infection including, but not limited to, herpes encephalitis, disseminated herpes simplex, and herpes zoster pandemic.
- Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months prior to randomization, or use of any topical cytotoxic or topical immunosuppressive drug within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
- Receipt of a biologic or other clinical trial drug within 3 months or 5 half-lives, whichever is longer, prior to randomization.
- Has undergone surgery within 4 weeks prior to randomization or is scheduled to undergo surgery during the study.
- Who has lost or donated more than 400 mL of blood within 4 weeks prior to randomization.
- Who have taken any prescription, over-the-counter, and herbal medications, except vitamin products, within 4 weeks prior to randomization.
- Persons with potential blood collection difficulties and a history of needle and blood sickness.
- Allergy to any of the known components of TQH3906 or any previous history of severe drug allergy.
- History of substance abuse or positive urine drug screen.
- Who have smoked more than 5 cigarettes/day or used an equivalent amount of nicotine or nicotine-containing products in the 3 months prior to randomization, or who are unable to discontinue the use of any tobacco-based products during the trial.
- Those who have chronic alcohol abuse or who have consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol by volume or 150 mL of wine) in the 3 months prior to screening or who are unable to abstain from alcohol for the duration of the trial, or who have a positive breath test for alcohol.
- Have any other valid medical, psychiatric, or social reason that, in the opinion of the investigator, precludes participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQH3906 Capsules in Healthy Volunteers
This study was divided into three parts: single and multiple dosing and food effect study, which were designed to evaluate the safety and tolerability of TQH3906 capsules administered in single or multiple dose escalation in healthy adult subjects.
- Conditions
- Psoriasis
- Being tested
- TQH3906 capsule, TQH3906 placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH3906 capsuleDrug
TQH3906 is a kinase inhibitor.
TQH3906 placeboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| TQH3906 capsule | Experimental | TQH3906 capsule for oral administration as a single or multiple dose for 7days. Receives: Drug: TQH3906 capsule |
| TQH3906 placebo capsule | Placebo comparator | TQH3906 placebo capsule for oral administration as single dose or multiple dose for 7days. Receives: Drug: TQH3906 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
Incidence of adverse events (AE)
Measured: Up to 18 days
Serious Adverse Events (SAE)
Incidence of serious adverse events (SAE)
Measured: Up to 18 days
Treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 18 days
Secondary outcomes (15)
Time to peak concentration (Tmax)
The time it takes to reach the peak concentration
Measured: Up to 18 days
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: Up to 18 days
Area under the blood concentration-time curve
The amount of drug absorbed into the circulation after administration of a single dose can be estimated from the area under the blood concentration-time curve, with Auc in units of concentration * time.
Measured: Up to 18 days
Apparent volume of distribution (Vd/F)
It is the ratio of the amount of drug in the body to the blood concentration of the drug when the drug reaches dynamic equilibrium in the body is called the apparent volume of distribution.
Measured: Up to 18 days
Plasma clearance (CL/F)
It is the sum of drug clearance by the liver and kidneys, etc., i.e., how many volumes of plasma are cleared of drug per unit of time in L/h, or L/(kg-h) if calculated on the basis of body weight.
Measured: Up to 18 days
Plasma elimination half-life (t1/2)
The time required for the concentration of a drug in the blood or the amount of drug in the body to be reduced to 1/2. The time required for absorption, distribution and elimination of half the amount of drug (or blood concentration) in the body becomes the absorption half-life, distribution half-life and elimination half-life, respectively.
Measured: Up to 18 days
Steady-state peaking time (Tmax, ss)
The time required to reach a steady-state peak concentration after administration.
Measured: Up to 18 days
Steady state peak concentration (Cmax, ss)
The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the highest steady-state blood drug concentration being the peak steady-state blood drug concentration.
Measured: Up to 18 days
Steady state valley concentration (Cmin, ss)
The steady-state blood drug concentration is a serrated plasma drug concentration curve, with the lowest steady-state blood drug concentration being the trough of the steady-state blood drug concentration.
Measured: Up to 18 days
Average steady-state blood drug concentration (Cav, ss)
The average concentration reached when the drug concentration reaches a steady state after a continuous given dose of medication.
Measured: Up to 18 days
Area under steady-state blood drug concentration time curve (AUC0- τ)
After a single dose administration, the amount of medication absorbed into the human bloodstream can be estimated using the area under the blood drug concentration time curve, with the unit of Auc being concentration * time.
Measured: Up to 18 days
Accumulation ratio (Rac)
The ratio of the required dose for a single administration to the total dose required for a split administration.
Measured: Up to 18 days
Renal clearance rate (CLr/F)
The ability of both kidneys to completely remove a substance equivalent to several milliliters of plasma within one minute.
Measured: Up to 18 days
INF-γ release
Inhibition efficiency of INF-γ release by TQH3906 in IL-12/IL-18-stimulated peripheral blood mononuclear cells from subjects.
Measured: Up to 18 days
QTcF interval
Effect of TQH3906 on the QTcF interval in healthy subjects.
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start2 Feb 2024
- Primary completion27 Apr 2025
- Study completion27 Apr 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230588
- Sponsor's protocol ID
- TQH3906-I-01
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of TQH3906 Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06230588
- Acronym / sponsor ID
- TQH3906-I-01
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 27 Apr 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 30 Jan 2024 (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.
This study was divided into three parts: single and multiple dosing and food effect study, which were designed to evaluate the safety and tolerability of TQH3906 capsules administered in single or multiple dose escalation in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQH3906 capsule | Experimental | Drug: TQH3906 capsuleTQH3906 capsule for oral administration as a single or multiple dose for 7days. |
| TQH3906 placebo capsule | Placebo comparator | Drug: TQH3906 placeboTQH3906 placebo capsule for oral administration as single dose or multiple dose for 7days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 18-55 years (including 18 and 55 years), regardless of gender.
- Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) of 19-26 kg/m2 (included).
- Be in good health with no abnormalities of clinical significance according to medical history, clinical symptoms, vital signs, physical examination, 12-lead electrocardiogram, chest radiographs, abdominal ultrasound, and laboratory tests
- Have a full understanding of the study, participate in the trial voluntarily, and have signed a written informed consent form.
- Subjects (including partners) are willing to voluntarily use appropriate and effective contraception from screening until 3 months after the last dose of study drug.
Key exclusion criteria (24 listed)
- Pregnant, lactating women.
- Previous history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, infectious, hematologic, neurologic, or psychiatric disorders/abnormalities, or related chronic illnesses, or acute illnesses, which the investigator assesses as contraindicated for participation in the trial.
- Have a QTc > 450 ms in males and > 470 ms in females at screening, or whose Electrocardiograph (ECG) is unsuitable for Concentration QT (C-QT) measurement (at the discretion of the investigator).
- The presence of risk factors and history of tip-twist ventricular tachycardia including, but not limited to: unexplained syncope, long QT syndrome, heart failure, or clinically significant abnormal laboratory tests (including hypokalemia, hypercalcemia, or hypomagnesemia) identified at Screening.
- Presence of abnormal serum virology at screening;
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 |
|---|---|---|
| TQH3906 capsuleTQH3906 is a kinase inhibitor. | Drug | TQH3906 capsule |
| TQH3906 placeboPlacebo Comparator | Drug | TQH3906 placebo capsule |
Primary outcome
Adverse events (AE)
Time frame: Up to 18 days
Incidence of adverse events (AE)
Serious Adverse Events (SAE)
Time frame: Up to 18 days
Incidence of serious adverse events (SAE)
Treatment-emergent adverse events (TEAEs)
Time frame: Up to 18 days
Incidence of treatment-emergent adverse events (TEAEs)
15 secondary outcomes
Time to peak concentration (Tmax)
Time frame: Up to 18 days
Peak concentration (Cmax)
Time frame: Up to 18 days
Area under the blood concentration-time curve
Time frame: Up to 18 days
Apparent volume of distribution (Vd/F)
Time frame: Up to 18 days
Plasma clearance (CL/F)
Time frame: Up to 18 days
Plasma elimination half-life (t1/2)
Time frame: Up to 18 days
Steady-state peaking time (Tmax, ss)
Time frame: Up to 18 days
Steady state peak concentration (Cmax, ss)
Time frame: Up to 18 days
Steady state valley concentration (Cmin, ss)
Time frame: Up to 18 days
Average steady-state blood drug concentration (Cav, ss)
Time frame: Up to 18 days
Area under steady-state blood drug concentration time curve (AUC0- τ)
Time frame: Up to 18 days
Accumulation ratio (Rac)
Time frame: Up to 18 days
Renal clearance rate (CLr/F)
Time frame: Up to 18 days
INF-γ release
Time frame: Up to 18 days
QTcF interval
Time frame: Up to 18 days
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 16 Jul 2025.
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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 TQH3906 capsule 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 24 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 16 Jul 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) (time frame: Up to 18 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.