PHA1AEarly Phase 1NCT03931668
Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers
A Early Phase 1 study testing TPN-672 in people with PHA1A, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- PHA1A
- What is being tested?
- TPN-672
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2019to 17 Dec 2020
- Phase
- Early 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight > 50kg(male) or > 45kg(female), 19 <BMI<26 kg/m2.
- Good communication with investigators, willingness and ability to abide by the lifestyle restrictions stipulated in clinical trial
- Women or men within childbearing age do not have a fertility plan within 3 months after the end of the trial, and agree to adopt contraceptive measures approved (such as intrauterine device, condom, sperm killing gel, condom, uterine cap, etc.) throughout the clinical trial period.
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, can complete the entire trial process according to the requirements of the trial.
Who cannot join
- Investigator determined that there were diseases or functional disorders affecting clinical trials, including, but not limited to, central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system.
- Mental illness or previous history of mental illness;
- Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc.
- Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- Any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism and excretion, or that may pose a hazard to the subjects participating in the study, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.
- Those who are known to have a history of drug allergy, allergic disease or allergic constitution of the tested drug ingredients or similar drugs;
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- Smokers who smoked more than 10 cigarettes or the same amount of tobacco per day in the first year of screening;
- Alcohol addiction within 1 year before screening, with an average weekly alcohol intake of more than 14 units (1 unit = 285 ml beer or 25 ml spirits or 150 ml wine) or positive alcohol breath test;
- Those who had a history of drug abuse or drug abuse within 1 year before screening, or those who had positive urinary drug screening;
- Physical examination, current medical history and vital signs were found to be abnormal by researchers and have clinical significance.
- Resting pulse rate < 55/min or > 100/min; systolic pressure < 90 mmHg or > 140 mmHg, diastolic pressure < 60 mmHg or > 90 mmHg;
- 12-lead electrocardiogram (ECG) examination was found to be abnormal by investigator and had clinical significance; or the following ECG abnormalities occurred: PR interval > 220 ms, QRS complex wave duration > 120 ms, long QT syndrome (QTc > 450 ms);
- Family history of sudden cardiac death (less than 40 years old);
- Abnormal blood routine examination and urine routine examination have clinical significance.
- Aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr), urea nitrogen (BUN) exceeded the normal upper limit.
- HBsAg, HCV-Ab, HIV-Ab and TRUST positive patients;
- Pregnant or lactating women or male subjects whose spouses have child-rearing plans within three months;
- Those who took any medicine within 2 weeks before admission, including prescription and non-prescription drugs;
- Blood donation or blood loss (> 200 ml) within 3 months before admission, or a history of using blood products;
- Participated in any clinical trials within 3 months before admission;
- Those who had a history of operation within 3 months before admission, or who had not recovered from the operation, or who had anticipated operation plan during the trial period;
- Do not agree to abide by the following conditions during the experiment: prohibit the use of tobacco, alcohol or caffeine-containing beverages, avoid strenuous exercise;
- Personnel directly related to this clinical trial;
- Investigator believes that other subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang LI, MD PhD, 86-21-34773107, lhlh_5@163.com
Huafang LI, MD PhD
About this study
Official title: A Single Site, Randomized, Double-blind, Placebo-controlled, Incremental Phase I Clinical Trial: to Evaluate the Tolerance, PK and PD Effects of TPN-672 Maleate in Chinese Healthy Volunteers After Single Dose Administration.
This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.
- Conditions
- PHA1A
- Being tested
- TPN-672
- Keywords
- tolerance, pharmacokinetics, pharmacodynamics, TPN-672
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN-672Drug
Also called TPN-672 maleate tablet
single dose of TPN-672 maleate tablet
| Study group | Role | What they receive |
|---|---|---|
| 0.125mg single dose | Experimental | single dose of TPN-672 0.125mg, 2 subjects Receives: Drug: TPN-672 |
| 0.25mg single dose | Experimental | single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
| 0.5mg single dose | Experimental | single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
| 1mg single dose | Experimental | single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
| 2mg single dose | Experimental | single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
| 3mg single dose | Experimental | single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
| 4mg single dose | Experimental | single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo) Receives: Drug: TPN-672 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of Subjects with adverse events during clinical trial
Measured: 48 hours
Cmax
Maximum Plasma Concentration
Measured: 48 hours
AUC
Area Under the Curve
Measured: 48 hours
Tmax
Time to Cmax
Measured: 48 hours
T1/2
Time of half life
Measured: 48 hours
ACR
Apparent Clearance Rate
Measured: 48 hours
ADV
Apparent Distribution Volume
Measured: 48 hours
Secondary outcomes (22)
prolactin
serum prolactin test
Measured: 48 hours
temperature
ear temperature
Measured: 48 hours
pulse rate
pulse rate
Measured: 48 hours
respiratory
frequency of respiratory per minute
Measured: 48 hours
blood pressure
lying blood pressure， systolic and diastolic
Measured: 48 hours
electrocardiogram(ECG)
the number of subjects with abnormal ECG report by 12-lead electrocardiogram
Measured: 48 hours
QTc
QTc interval
Measured: 48 hours
Extrapyramidal symptoms
Simpson Angus Rating Scale (SAS), total score ranges from 0 to 40, of which lower values represent a better outcome.
Measured: 48 hours
Involuntary Movement
Abnormal Involuntary Movement Scale (AIMS), total score ranges from 0 to 14, of which lower values represent a better outcome.
Measured: 48 hours
Akathisia
Barnes Akathisia Rating Scale (BARS), total score ranges from 0 to 40, of which lower values represent a better outcome.
Measured: 48 hours
IL-6
Serum concentration of Interleukin-6
Measured: 48 hours
IL-4
Serum concentration of Interleukin-4
Measured: 48 hours
IL-1
Serum concentration of Interleukin-1
Measured: 48 hours
IL-2
Serum concentration of Interleukin-2
Measured: 48 hours
INF-gamma
Serum concentration of Interferon-gamma
Measured: 48 hours
TNF-alpha
Serum concentration of Tumor necrosis factor-alpha
Measured: 48 hours
5-HT
Serum concentration of serotonin
Measured: 48 hours
DA
Serum concentration of Dopamine
Measured: 48 hours
NE
Serum concentration of Norepinephrine
Measured: 48 hours
BDNF
Serum concentration of Brain-derived neurotrophic factor
Measured: 48 hours
Glutamic acid
Serum concentration of Glutamic acid
Measured: 48 hours
GABA
Serum concentration of gamma-aminobutyric acid
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start17 Apr 2019
- Primary completion17 Oct 2020 (estimated)
- Study completion17 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHA1AStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Kanion Pharmaceutical Co.
- Responsible party
- Sponsor
- Investigators
- Yifeng SHEN, MD PhD, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931668
- Sponsor's protocol ID
- SMHC-180
- Other IDs
- TPN672-KYHY-201801
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site, Randomized, Double-blind, Placebo-controlled, Incremental Phase I Clinical Trial: to Evaluate the Tolerance, PK and PD Effects of TPN-672 Maleate in Chinese Healthy Volunteers After Single Dose Administration.
- ClinicalTrials.gov ID
- NCT03931668
- Acronym / sponsor ID
- SMHC-180
- Conditions
- PHA1A
- Keywords
- tolerance, pharmacokinetics, pharmacodynamics, TPN-672
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Jiangsu Kanion Pharmaceutical Co.
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 17 Oct 2020 (estimated)
- Study completion
- 17 Dec 2020 (estimated)
- First posted
- 30 Apr 2019 (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 is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0.125mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.125mg, 2 subjects |
| 0.25mg single dose | Experimental | Drug: TPN-672single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| 0.5mg single dose | Experimental | Drug: TPN-672single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| 1mg single dose | Experimental | Drug: TPN-672single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| 2mg single dose | Experimental | Drug: TPN-672single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| 3mg single dose | Experimental | Drug: TPN-672single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| 4mg single dose | Experimental | Drug: TPN-672single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body weight > 50kg(male) or > 45kg(female), 19 <BMI<26 kg/m2.
- Good communication with investigators, willingness and ability to abide by the lifestyle restrictions stipulated in clinical trial
- Women or men within childbearing age do not have a fertility plan within 3 months after the end of the trial, and agree to adopt contraceptive measures approved (such as intrauterine device, condom, sperm killing gel, condom, uterine cap, etc.) throughout the clinical trial period.
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, can complete the entire trial process according to the requirements of the trial.
Key exclusion criteria (24 listed)
- Investigator determined that there were diseases or functional disorders affecting clinical trials, including, but not limited to, central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system.
- Mental illness or previous history of mental illness;
- Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc.
- Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- Any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism and excretion, or that may pose a hazard to the subjects participating in the study, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.
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 |
|---|---|---|
| TPN-672Also: TPN-672 maleate tabletsingle dose of TPN-672 maleate tablet | Drug | 0.125mg single dose, 0.25mg single dose, 0.5mg single dose, 1mg single dose, 2mg single dose, 3mg single dose, 4mg single dose |
Primary outcome
Adverse events
Time frame: 48 hours
Number of Subjects with adverse events during clinical trial
Cmax
Time frame: 48 hours
Maximum Plasma Concentration
AUC
Time frame: 48 hours
Area Under the Curve
Tmax
Time frame: 48 hours
Time to Cmax
T1/2
Time frame: 48 hours
Time of half life
ACR
Time frame: 48 hours
Apparent Clearance Rate
ADV
Time frame: 48 hours
Apparent Distribution Volume
22 secondary outcomes
prolactin
Time frame: 48 hours
temperature
Time frame: 48 hours
pulse rate
Time frame: 48 hours
respiratory
Time frame: 48 hours
blood pressure
Time frame: 48 hours
electrocardiogram(ECG)
Time frame: 48 hours
QTc
Time frame: 48 hours
Extrapyramidal symptoms
Time frame: 48 hours
Involuntary Movement
Time frame: 48 hours
Akathisia
Time frame: 48 hours
IL-6
Time frame: 48 hours
IL-4
Time frame: 48 hours
IL-1
Time frame: 48 hours
IL-2
Time frame: 48 hours
INF-gamma
Time frame: 48 hours
TNF-alpha
Time frame: 48 hours
5-HT
Time frame: 48 hours
DA
Time frame: 48 hours
NE
Time frame: 48 hours
BDNF
Time frame: 48 hours
Glutamic acid
Time frame: 48 hours
GABA
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: No
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.
Yifeng SHEN, MD PhD study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TPN-672 in people with PHA1A, run by Shanghai Mental Health Center 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 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2019. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifeng SHEN, MD PhD (86-21-34773657, shenyifeng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 48 hours). The study lists 7 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 23 Dec 2019.