Overweight,ObesityPhase 1NCT07307638
Dose-escalation and Food Effect Study of ZT006 in Healthy, Overweight and Obese Participants
A Phase 1 study testing ZT006 in people with Overweight,Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
Trial summary
ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight,Obesity
- What is being tested?
- ZT006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2024to 24 Jun 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
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, 12-lead electrocardiogram and clinical laboratory tests (hematology, urinalysis, chemistry, coagulation), as judged by the investigator.
- Male or female, age between 18 - 55 years (both inclusive) at the time of signing of the informed consent.
- Body mass index (BMI) 19.0 - 35.0 kg/m²(both inclusive). Body weight >50.0 kg for male participants and >45.0 kg for female participants. BMI 19 - 28.0 kg/m²(both inclusive) for single-dose escalation study, BMI 19.0 - 28.0 kg/m²(both inclusive) for cohorts 1 and 2 of multiple-dose escalation study, BMI 24.0 - 35.0 kg/m²(both inclusive) for cohorts 3 and 4 of multiple-dose escalation study.
- Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.
Who cannot join
- Known hypersensitivity to the study drug or excipients or GLP-1 receptor agonists.
- Medical history of hypoglycemia.
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of pancreatitis or symptomatic gallbladder disease.
- Previous diagnosis of endocrine disorders or monogenic mutations causing obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-induced obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
- Use of GLP-1 receptor agonists within 30 days or 5 half-lives (whichever is longer) before the first dose of the investigational intervention.
- Glycated hemoglobin (HbA1c) > 6.0% or fasting plasma glucose < 3.9 mmol/L or > 6.1 mmol/L at screening, or diagnosed with diabetes mellitus of type 1 or type 2 diabetes or other specific types derived from other causes.
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- Aspartate aminotransferase ≥ 2 × upper limit of normal (ULN), Alanine aminotransferase ≥ 2 × ULN, or total bilirubin ≥ 1.5 × ULN
- Calcitonin above ULN at screening.
- Other clinically significant diseases detected within 12 months before screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular diseases).
- Use of prescription drugs (excluding topical eye/nose drops and creams without systemic exposure risk), over-the-counter drugs, dietary supplements, vitamins, or herbal medicines (excluding routine vitamins) within 2 weeks before screening.
- Long-term use of medications directly affecting gastrointestinal motility prior to screening. Use of weight-loss medications (including but not limited to orlistat) within 3 months before dosing.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ZT006 as Well as the Food Effect on the Pharmacokinetics of ZT006 in Healthy, Overweight and Obese Participants
ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. single dose-escalation, multiple dose-escalation, food effect on the pharmacokinetics of ZT006.
In the single dose-escalation study, participants will receive a single dose (ZT006 dose level 1 - 5 or corresponding placebo) of ZT006 under fasted condition. A higher dose can only be given after obtaining acceptable safety and tolerability data for at least 7 days after the previous dose. After study drug administration, there will be a 7-day in-house period for safety observation and pharmacokinetics samples collection. Participants will join ambulatory visits until 42 days post-dose.
Read more
In the multiple dose-escalation study, participants will receive a daily dose of ZT006 or corresponding placebo over 42 days in a dose up-titration fashion according to the following regimen:
- Cohort 1: dose level 1 - dose level 2 - dose level 3
- Cohort 2: dose level 1 - dose level 2 - dose level 3 - dose level 4
- Cohort 3: dose level 2 - dose level 3 - dose level 4
- Cohort 4: dose level 2 - dose level 3 - dose level 4 - dose level 5
Dosing of a cohort with higher drug exposure can only be done after evaluation of safety and tolerability data for at least 14 days after the first dose in the previous cohort. Participants will join ambulatory visits until 35 days after the last dose.
To evaluate the food effect on the pharmacokinetics of ZT006, participants who have received single dose of ZT006 or placebo of dose level 4 in the single dose-escalation study will receive another dose of ZT006 or placebo after a high fat, high caloric breakfast.
- Conditions
- Overweight,Obesity
- Being tested
- ZT006, Placebo of ZT006
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZT006Drug
Participants will receive a single dose of ZT006 of dose level 1 under fasted condition.
ZT006Drug
Participants will receive a single dose of ZT006 of dose level 2 under fasted condition.
ZT006Drug
Participants will receive a single dose of ZT006 of dose level 3 under fasted condition.
ZT006Drug
Participants will receive a single dose of ZT006 of dose level 4 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.
ZT006Drug
Participants will receive a single dose of ZT006 of dose level 5 under fasted condition.
ZT006Drug
Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 28 days.
ZT006Drug
Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 14 days, then dose level 4 for 14 days.
ZT006Drug
Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 28 days.
ZT006Drug
Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 14 days, then dose level 5 for 14 days.
Placebo of ZT006Drug
Participants will receive a single dose of placebo of ZT006 under fasted condition.
Placebo of ZT006Drug
Participants will receive a single dose of placebo of ZT006 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.
Placebo of ZT006Drug
Participants will receive daily doses of placebo of ZT006 for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| ZT006 tablet, dose level 1, single dose, fasted | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, dose level 2, single dose, fasted | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, dose level 3, single dose, fasted | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, dose level 4, single dose, fasted and fed | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, dose level 5, single dose, fasted | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 1 | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 2 | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 3 | Experimental | Not described Receives: Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 4 | Experimental | Not described Receives: Drug: ZT006 |
| placebo of ZT006, single dose, fasted | Placebo comparator | Not described Receives: Drug: Placebo of ZT006 |
| placebo of ZT006, single dose, fasted and fed | Placebo comparator | Not described Receives: Drug: Placebo of ZT006 |
| placebo of ZT006, multiple doses | Placebo comparator | Not described Receives: Drug: Placebo of ZT006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment-emergent adverse events after single dose administration under fasted condition.
Summarized from adverse event reporting in %
Measured: From baseline to Day 43
Rate of treatment-emergent adverse events during and after multiple-dose administration.
Summarized from adverse event reporting in %
Measured: From baseline to end of study (Day 77)
Rate of treatment-emergent adverse events after single dose administration under fed condition.
Summarized from adverse event reporting in %
Measured: From Day 44 to end of study (Day 86)
Secondary outcomes (14)
Area under the concentration-time curve from time zero to infinity after single-dose administration under fasted condition.
Measured in ng*h/mL
Measured: From baseline to Day 43
Maximal observed concentration after single-dose administration under fasted condition.
Measured in ng/mL
Measured: From baseline to Day 43
Time to reach the maximal observed concentration after single-dose administration under fasted condition.
Measured in hours
Measured: From baseline to Day 43
Terminal half-life after single-dose administration under fasted condition.
Measured in hours
Measured: From baseline to Day 43
Area under the concentration-time curve during the dosing interval at steady state.
Measured in ng*h/mL
Measured: Day 42 to Day 77
Maximal observed concentration at steady state.
Measured in ng/mL
Measured: Day 42 to Day 77
Time to reach the maximal observed concentration at steady state.
Measured in hours
Measured: From Day 42 to Day 77
Terminal half-life at steady state.
Measured in hours
Measured: From Day 42 to Day 77
Area under the concentration-time curve from time zero to infinity after single-dose administration under fed condition.
Measured in ng*h/mL
Measured: From Day 44 to end of study (Day 86)
Maximal observed concentration after single-dose administration under fed condition.
Measured in ng/mL
Measured: From Day 44 to end of study (Day 86)
Time to reach the maximal observed concentration after single-dose administration under fed condition.
Measured in hours
Measured: From Day 44 to end of study (Day 86)
Terminal half-life after single-dose administration under fed condition.
Measured in hours
Measured: From Day 44 to end of study (Day 86)
Incidence of ZT006 anti-drug antibody after single-dose administration under fasted condition.
Measured in %
Measured: From baseline to Day 43
Incidence of ZT006 anti-drug antibody during and after multiple-dose administration.
Measured in %
Measured: From baseline to end of study (Day 77)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start28 Nov 2024
- Primary completion14 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight,ObesityStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, MD, Principal investigator, The Second Hospital of Anhui Medical UniversityYijun Du, Master, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307638
- Sponsor's protocol ID
- BJQL-ZT006-1001
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ZT006 as Well as the Food Effect on the Pharmacokinetics of ZT006 in Healthy, Overweight and Obese Participants
- ClinicalTrials.gov ID
- NCT07307638
- Acronym / sponsor ID
- BJQL-ZT006-1001
- Conditions
- Overweight,Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 29 Dec 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.
ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. single dose-escalation, multiple dose-escalation, food effect on the pharmacokinetics of ZT006.
In the single dose-escalation study, participants will receive a single dose (ZT006 dose level 1 - 5 or corresponding placebo) of ZT006 under fasted condition. A higher dose can only be given after obtaining acceptable safety and tolerability data for at least 7 days after the previous dose. After study drug administration, there will be a 7-day in-house period for safety observation and pharmacokinetics samples collection. Participants will join ambulatory visits until 42 days post-dose.
In the multiple dose-escalation study, participants will receive a daily dose of ZT006 or corresponding placebo over 42 days in a dose up-titration fashion according to the following regimen:
- Cohort 1: dose level 1 - dose level 2 - dose level 3
- Cohort 2: dose level 1 - dose level 2 - dose level 3 - dose level 4
- Cohort 3: dose level 2 - dose level 3 - dose level 4
- Cohort 4: dose level 2 - dose level 3 - dose level 4 - dose level 5
Dosing of a cohort with higher drug exposure can only be done after evaluation of safety and tolerability data for at least 14 days after the first dose in the previous cohort. Participants will join ambulatory visits until 35 days after the last dose.
To evaluate the food effect on the pharmacokinetics of ZT006, participants who have received single dose of ZT006 or placebo of dose level 4 in the single dose-escalation study will receive another dose of ZT006 or placebo after a high fat, high caloric breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| ZT006 tablet, dose level 1, single dose, fasted | Experimental | Drug: ZT006 |
| ZT006 tablet, dose level 2, single dose, fasted | Experimental | Drug: ZT006 |
| ZT006 tablet, dose level 3, single dose, fasted | Experimental | Drug: ZT006 |
| ZT006 tablet, dose level 4, single dose, fasted and fed | Experimental | Drug: ZT006 |
| ZT006 tablet, dose level 5, single dose, fasted | Experimental | Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 1 | Experimental | Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 2 | Experimental | Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 3 | Experimental | Drug: ZT006 |
| ZT006 tablet, multiple doses, cohort 4 | Experimental | Drug: ZT006 |
| placebo of ZT006, single dose, fasted | Placebo comparator | Drug: Placebo of ZT006 |
| placebo of ZT006, single dose, fasted and fed | Placebo comparator | Drug: Placebo of ZT006 |
| placebo of ZT006, multiple doses | Placebo comparator | Drug: Placebo of ZT006 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, 12-lead electrocardiogram and clinical laboratory tests (hematology, urinalysis, chemistry, coagulation), as judged by the investigator.
- Male or female, age between 18 - 55 years (both inclusive) at the time of signing of the informed consent.
- Body mass index (BMI) 19.0 - 35.0 kg/m²(both inclusive). Body weight >50.0 kg for male participants and >45.0 kg for female participants. BMI 19 - 28.0 kg/m²(both inclusive) for single-dose escalation study, BMI 19.0 - 28.0 kg/m²(both inclusive) for cohorts 1 and 2 of multiple-dose escalation study, BMI 24.0 - 35.0 kg/m²(both inclusive) for cohorts 3 and 4 of multiple-dose escalation study.
- Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.
Key exclusion criteria (11 listed)
- Known hypersensitivity to the study drug or excipients or GLP-1 receptor agonists.
- Medical history of hypoglycemia.
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of pancreatitis or symptomatic gallbladder disease.
- Previous diagnosis of endocrine disorders or monogenic mutations causing obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-induced obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
- Use of GLP-1 receptor agonists within 30 days or 5 half-lives (whichever is longer) before the first dose of the investigational intervention.
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 |
|---|---|---|
| ZT006Participants will receive a single dose of ZT006 of dose level 1 under fasted condition. | Drug | ZT006 tablet, dose level 1, single dose, fasted |
| ZT006Participants will receive a single dose of ZT006 of dose level 2 under fasted condition. | Drug | ZT006 tablet, dose level 2, single dose, fasted |
| ZT006Participants will receive a single dose of ZT006 of dose level 3 under fasted condition. | Drug | ZT006 tablet, dose level 3, single dose, fasted |
| ZT006Participants will receive a single dose of ZT006 of dose level 4 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2. | Drug | ZT006 tablet, dose level 4, single dose, fasted and fed |
| ZT006Participants will receive a single dose of ZT006 of dose level 5 under fasted condition. | Drug | ZT006 tablet, dose level 5, single dose, fasted |
| ZT006Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 28 days. | Drug | ZT006 tablet, multiple doses, cohort 1 |
| ZT006Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 14 days, then dose level 4 for 14 days. | Drug | ZT006 tablet, multiple doses, cohort 2 |
| ZT006Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 28 days. | Drug | ZT006 tablet, multiple doses, cohort 3 |
| ZT006Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 14 days, then dose level 5 for 14 days. | Drug | ZT006 tablet, multiple doses, cohort 4 |
| Placebo of ZT006Participants will receive a single dose of placebo of ZT006 under fasted condition. | Drug | placebo of ZT006, single dose, fasted |
| Placebo of ZT006Participants will receive a single dose of placebo of ZT006 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2. | Drug | placebo of ZT006, single dose, fasted and fed |
| Placebo of ZT006Participants will receive daily doses of placebo of ZT006 for 42 days. | Drug | placebo of ZT006, multiple doses |
Primary outcome
Rate of treatment-emergent adverse events after single dose administration under fasted condition.
Time frame: From baseline to Day 43
Summarized from adverse event reporting in %
Rate of treatment-emergent adverse events during and after multiple-dose administration.
Time frame: From baseline to end of study (Day 77)
Summarized from adverse event reporting in %
Rate of treatment-emergent adverse events after single dose administration under fed condition.
Time frame: From Day 44 to end of study (Day 86)
Summarized from adverse event reporting in %
14 secondary outcomes
Area under the concentration-time curve from time zero to infinity after single-dose administration under fasted condition.
Time frame: From baseline to Day 43
Maximal observed concentration after single-dose administration under fasted condition.
Time frame: From baseline to Day 43
Time to reach the maximal observed concentration after single-dose administration under fasted condition.
Time frame: From baseline to Day 43
Terminal half-life after single-dose administration under fasted condition.
Time frame: From baseline to Day 43
Area under the concentration-time curve during the dosing interval at steady state.
Time frame: Day 42 to Day 77
Maximal observed concentration at steady state.
Time frame: Day 42 to Day 77
Time to reach the maximal observed concentration at steady state.
Time frame: From Day 42 to Day 77
Terminal half-life at steady state.
Time frame: From Day 42 to Day 77
Area under the concentration-time curve from time zero to infinity after single-dose administration under fed condition.
Time frame: From Day 44 to end of study (Day 86)
Maximal observed concentration after single-dose administration under fed condition.
Time frame: From Day 44 to end of study (Day 86)
Time to reach the maximal observed concentration after single-dose administration under fed condition.
Time frame: From Day 44 to end of study (Day 86)
Terminal half-life after single-dose administration under fed condition.
Time frame: From Day 44 to end of study (Day 86)
Incidence of ZT006 anti-drug antibody after single-dose administration under fasted condition.
Time frame: From baseline to Day 43
Incidence of ZT006 anti-drug antibody during and after multiple-dose administration.
Time frame: From baseline to end of study (Day 77)
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 29 Dec 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.
Wei Hu, MD principal investigator
The Second Hospital of Anhui Medical University
Yijun Du, Master principal investigator
The Second Hospital of Anhui Medical University
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 ZT006 in people with Overweight,Obesity, run by Beijing QL Biopharmaceutical 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 4 inclusion and 11 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 29 Dec 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?
Rate of treatment-emergent adverse events after single dose administration under fasted condition. (time frame: From baseline to Day 43). 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 29 Dec 2025.