Healthy SubjectsPhase 1NCT07102251
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
A Phase 1 study testing HEC-007 injection in people with Healthy Subjects, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HEC-007 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SAD
- Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.
- Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)/height2 (m2), with a body mass index ranging from 19.0 to 35.0 kg/m2 (including boundary values).
- Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.
- Female subjects of childbearing potential or male subjects must agree to use effective contraception from signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.
Show all 12Show fewer
- Glycated hemoglobin (HbA1c) <5.7% during the screening period. MAD
- 1. Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- 2. Age between 18 to 65 years (inclusive), both male and female. 3. Obesity: BMI ≥28.0 kg/m2; or overweight: 24.0 <BMI <28.0 kg/m2, and with at least one of the following manifestations: prediabetes (as detailed in 14.4), hypertension, dyslipidemia, fatty liver, weight-bearing joint pain, obesity-related dyspnea, or obstructive sleep apnea syndrome.
- 4. At screening, weight change of < 5% over at least 12 weeks of diet and exercise control alone.
- 5. Female subjects of childbearing potential or male subjects must agree to use effective contraceptionfrom signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.
- 6. Glycated hemoglobin (HbA1c) <6.5% during the screening period.
Who cannot join
- SAD
- Those diagnosed with type 1, type 2, or other types of diabetes before screening;
- History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;
- Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;
- Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);
- Presence of clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders) during screening;
Show all 78Show fewer
- Diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption during screening;
- Major surgery within 3 months before screening or planned surgery during the study;
- History of hypersensitivity to the investigational product or any of its components, or allergic constitution (allergy to two or more drugs or foods).
- Use of medications (including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, etc.) within 3 months prior to screening that, in the investigator's judgment, significantly affect weight or glucose metabolism;
- Individuals who have undergone bariatric surgery prior to screening;
- Those with a history of recurrent skin disorders (e.g., urticaria) or skin lesions at the administration site;
- Those who received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) within 3 months prior to screening, or systemic glucocorticoid therapy within 1 month prior to screening;
- Female subjects with HbA1c <110 g/L or male subjects with HbA1c <120 g/L at screening, or any other known condition that interferes with HbA1c measurement;
- Those with suicidal behaviors or ideation within 6 months prior to screening;
- Use of GLP-1R, GLP-1R/GIPR, GLP-1R/GCGR, or GLP-1R/GIPR/GCGR agonists within 6 months prior to screening;
- Those with regular alcohol consumption within 3 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); or those with a positive alcohol breath test during screening; or those unable to comply with the protocol's alcohol restrictions;
- Those with a history of drug abuse or illicit drug use within 2 years prior to screening, or those with a positive urine drug screen before administration;
- Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from smoking during intensive PK blood sampling;
- Those with a history of needle or blood phobia, intolerance to venipuncture, or difficulty in blood collection;
- Those with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum-specific antibody;
- Alanine aminotransferase >1.5 × upper limit of normal (ULN), aspartate aminotransferase >1.5 × ULN, alkaline phosphatase >1.5 × ULN, or total bilirubin >1.5 × ULN at screening;
- Those with blood amylase or lipase > ULN at screening;
- Those with serum calcitonin ≥20 ng/L at screening;
- Those with fasting blood glucose ≥6.1 mmol/L or <3.9 mmol/L at screening;
- Those with glomerular filtration rate (GFR) <90 mL/min/1.73m2 at screening;
- Fridericia-corrected QT interval (QTcF=QT/RR0.33) >450 ms (for male) or >470 ms (for female) on 12-lead ECG at screening;
- Use of strong inhibitors or inducers of hepatic metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4, and 3A5) within 4 weeks prior to the first dose, including strong inhibitors such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc., or strong inducers such as rifampin, carbamazepine, phenytoin sodium, St. John's wort, etc.;
- Use of any prescription drugs, over-the-counter medications, vitamin products, or Chinese herbal medicines within 2 weeks prior to the first dose;
- Consumption of any foods or beverages affecting CYP3A4, CYP2E1, or CYP2D6 metabolic enzymes, such as grapefruit or grapefruit-containing beverages, within 48 hours prior to the first dose;
- Ingestion of chocolate, any caffeine-containing or xanthine-rich food or beverage within 48 hours prior to the first dose;
- Blood donation ≥200 mL, any component blood donation, or total blood loss ≥200 mL due to any reason within 3 months prior to screening, or a history of blood transfusion or blood product use;
- Participation in other clinical trials within 3 months prior to screening (subjects who withdrew from the study before treatment, i.e., were not randomized or did not receive treatment, may be enrolled in this study);
- Occurrence of acute illness or concomitant medication use from the signing of the informed consent form until the first dose;
- Female subjects who are currently breastfeeding or have a positive pregnancy test result at screening;
- Subjects deemed by the investigator to have other factors unsuitable for participation in this trial.
- MAD
- Those diagnosed with type 1, type 2, or other types of diabetes before screening;
- Those diagnosed with overweight or obesity caused by other diseases or medications, such as Cushing's syndrome;
- History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;
- Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;
- Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);
- Presence of clinically significant diseases at screening, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders (excluding weight-related comorbidities);
- Any of the following diseases or medical histories within 6 months prior to screening or before randomization: cardiac insufficiency (New York Heart Association [NYHA] Class III or IV), myocardial infarction, unstable angina, uncontrolled arrhythmias requiring treatment (including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second- to third-degree atrioventricular block, sick sinus syndrome, etc.), coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography allowed), cerebrovascular accident (ischemic stroke, hemorrhagic stroke, transient ischemic attack), cirrhosis, etc.;
- Diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption during screening;
- Major surgery within 3 months before screening or planned surgery during the study;
- History of hypersensitivity to the investigational product or any of its components, or to acetaminophen and its excipients, or allergic constitution (allergy to two or more drugs or foods);
- Use of medications (including prescription drugs, over-the-counter medications, Chinese herbal medicines, health supplements, etc.) within 3 months prior to screening that, in the investigator's judgment, significantly affect body weight;
- Subjects taking lipid-lowering or antihypertensive medications with unstable doses within 30 days prior to screening;
- Individuals who have undergone bariatric surgery prior to screening;
- Those with a history of recurrent skin disorders (e.g., urticaria) or skin lesions at the administration site;
- Those who received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) within 3 months prior to screening, or systemic glucocorticoid therapy within 1 month prior to screening;
- Female subjects with HbA1c <110 g/L or male subjects with HbA1c <120 g/L at screening, or any other known condition that interferes with HbA1c measurement;
- Those with suicidal behaviors or ideation within 6 months prior to screening;
- History of depression or other psychiatric disorders within 6 months prior to screening;
- Use of GLP-1R, GLP-1R/GIPR, GLP-1R/GCGR, or GLP-1R/GIPR/GCGR agonists within 6 months prior to screening;
- Those with regular alcohol consumption within 3 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); or those with a positive alcohol breath test during screening; or those unable to comply with the protocol's alcohol restrictions;
- Those with a history of drug abuse or illicit drug use within 2 years prior to screening, or those with a positive urine drug screen before the first dose;
- Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from smoking during intensive PK blood sampling;
- Those with a history of needle or blood phobia, intolerance to venipuncture, or difficulty in blood collection;
- Resting seated blood pressure at screening: systolic blood pressure >160 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <55 mmHg;
- Heart rate at screening >100 beats per minute or <50 beats per minute;
- Those with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum-specific antibody;
- Alanine aminotransferase >2 × ULN, aspartate aminotransferase >2 × ULN, alkaline phosphatase >1.5 × ULN, or total bilirubin >1.5 × ULN at screening;
- Blood amylase or lipase > ULN at screening;
- Those with serum calcitonin ≥20 ng/L at screening;
- Fasting triglyceride levels ≥5.6 mmol/L at screening;
- Fasting blood glucose ≥7.0 mmol/L or <3.9 mmol/L at screening; or OGTT 2-hour ≥11.1 mmol/L;
- Those with glomerular filtration rate (GFR) <90 mL/min/1.73m2 at screening;
- Fridericia-corrected QT interval (QTcF=QT/RR0.33) >450 ms (for male) or >470 ms (for female) on 12-lead ECG at screening; or severe arrhythmia (second-degree or higher atrioventricular block, ventricular tachycardia, etc.);
- Use of strong inhibitors or inducers of hepatic metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4, and 3A5) within 4 weeks prior to the first dose, including strong inhibitors such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc., or strong inducers such as rifampin, carbamazepine, phenytoin sodium, St. John's wort, etc.;
- Consumption of any foods or beverages affecting CYP3A4, CYP2E1, or CYP2D6 metabolic enzymes, such as grapefruit or grapefruit-containing beverages, within 48 hours prior to the first dose;
- Ingestion of chocolate, any caffeine-containing or xanthine-rich food or beverage within 48 hours prior to the first dose;
- Blood donation ≥200 mL, any component blood donation, or total blood loss ≥200 mL due to any reason within 3 months prior to screening, or a history of blood transfusion or blood product use;
- Participation in other clinical trials within 3 months prior to screening (subjects who withdrew from the study before treatment, i.e., were not randomized or did not receive treatment, may be enrolled in this study);
- Occurrence of acute illness or concomitant medication use from the signing of the informed consent form until the first dose;
- Female subjects who are currently breastfeeding or have a positive pregnancy test result at screening;
- Subjects deemed by the investigator to have other factors unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Anhui Medical University is a Grade A Tertiary General
Hefei, Anhui, 230601
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HEC-007 Injection After Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Overweight or Obese Subjects
This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects.
The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.
- Conditions
- Healthy Subjects
- Being tested
- HEC-007 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC-007 injectionDrug
Single dose escalation of HEC-007 injection in healthy subjects
PlaceboDrug
Single dose of placebo in healthy adults
HEC-007 injectionDrug
Multiple dose escalation of HEC-007 injection in Overweight or Obese Subjects
PlaceboDrug
Multiple dose of placebo in Overweight or Obese Subjects
| Study group | Role | What they receive |
|---|---|---|
| SAD Stage: HEC-007 Injection | Experimental | Administered once Receives: Drug: HEC-007 injection |
| SAD Stage: Placebo | Placebo comparator | Administered once Receives: Drug: Placebo |
| MAD Stage: HEC-007 injection | Experimental | Administered for multiple dose Receives: Drug: HEC-007 injection |
| MAD Stage: Placebo | Placebo comparator | Administered for multiple dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Screening period up to day 43/day 113
The maximum plasma concentration (Cmax)
Measured: Post-dose at day 1 to day 43/day 113
Time to maximum plasma concentration (Tmax)
Measured: Post-dose at day 1 to day 43/day 113
Terminal half-life (t1/2)
Measured: Post-dose at day 1 to day 43/day 113
Apparent clearance (CL/F)
Measured: Post-dose at day 1 to day 43/day 113
Apparent volume of distribution (Vz/F)
Measured: Post-dose at day 1 to day 43/day 113
Area Under the PlasmaConcentration-TimeCurve (AUC) of HEC-007
Measured: Post-dose at day 1 to day 43/day 113
Changes from baseline in Body Weight
Measured: Baseline period up to day 43/day 113
Changes from baseline in waist circumference
Measured: Baseline period up to day 43/day 113
Changes from baseline in Fasting Plasma Glucose
Measured: Baseline period up to day 43/day 113
Changes from baseline in Fasting Insulin
Measured: Baseline period up to day 43/day 113
Changes from baseline in fasting blood lipids
Measured: Baseline period up to day 43/day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start21 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Model description
- randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102251
- Sponsor's protocol ID
- HEC-007-OB-101
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HEC-007 Injection After Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT07102251
- Acronym / sponsor ID
- HEC-007-OB-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2025 (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 trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects.
The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| SAD Stage: HEC-007 Injection | Experimental | Drug: HEC-007 injectionAdministered once |
| SAD Stage: Placebo | Placebo comparator | Drug: PlaceboAdministered once |
| MAD Stage: HEC-007 injection | Experimental | Drug: HEC-007 injectionAdministered for multiple dose |
| MAD Stage: Placebo | Placebo comparator | Drug: PlaceboAdministered for multiple dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- SAD
- Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.
- Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)/height2 (m2), with a body mass index ranging from 19.0 to 35.0 kg/m2 (including boundary values).
- Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.
Key exclusion criteria (78 listed)
- SAD
- Those diagnosed with type 1, type 2, or other types of diabetes before screening;
- History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;
- Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;
- Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);
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 |
|---|---|---|
| HEC-007 injectionSingle dose escalation of HEC-007 injection in healthy subjects | Drug | SAD Stage: HEC-007 Injection |
| PlaceboSingle dose of placebo in healthy adults | Drug | SAD Stage: Placebo |
| HEC-007 injectionMultiple dose escalation of HEC-007 injection in Overweight or Obese Subjects | Drug | MAD Stage: HEC-007 injection |
| PlaceboMultiple dose of placebo in Overweight or Obese Subjects | Drug | MAD Stage: Placebo |
Primary outcome
Adverse events (AEs)
Time frame: Screening period up to day 43/day 113
The maximum plasma concentration (Cmax)
Time frame: Post-dose at day 1 to day 43/day 113
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at day 1 to day 43/day 113
Terminal half-life (t1/2)
Time frame: Post-dose at day 1 to day 43/day 113
Apparent clearance (CL/F)
Time frame: Post-dose at day 1 to day 43/day 113
Apparent volume of distribution (Vz/F)
Time frame: Post-dose at day 1 to day 43/day 113
Area Under the PlasmaConcentration-TimeCurve (AUC) of HEC-007
Time frame: Post-dose at day 1 to day 43/day 113
Changes from baseline in Body Weight
Time frame: Baseline period up to day 43/day 113
Changes from baseline in waist circumference
Time frame: Baseline period up to day 43/day 113
Changes from baseline in Fasting Plasma Glucose
Time frame: Baseline period up to day 43/day 113
Changes from baseline in Fasting Insulin
Time frame: Baseline period up to day 43/day 113
Changes from baseline in fasting blood lipids
Time frame: Baseline period up to day 43/day 113
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Related trials for Healthy Subjects
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
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 HEC-007 injection in people with Healthy Subjects, run by Sunshine Lake Pharma 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 12 inclusion and 78 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, Doctor of Medicine (+8613856086475, ayefygcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Screening period up to day 43/day 113). The study lists 12 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 27 Apr 2026.