HealthyPhase 1NCT06835296
A Study of Oral YUQ-A1007 in Healthy Volunteers
A Phase 1 study testing YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. in people with Healthy, run by Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. at 1 site in United States.
Trial summary
YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 has the potential to treat IBD. YUQ-A1007 has not been evaluated in human clinical studies. This study is first-in-human (FIH) study of YUQ-A1007. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent prior to the conduct of any study-related assessments.
- Aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
- Male and Female participants.
- Has body mass index (BMI) as 18.5-27.9 kg/m2 with total body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants at screening.
- With normal liver and kidney functions.
- With normal results of clinical laboratory tests or abnormal results of clinical laboratory tests deemed not clinically significant as per investigator judgement at screening and on admission to the CRU.
Show all 9Show fewer
- Willing and able to comply with the study requirements, including remaining at the CRU for the in-house portion of study participation.
- Agrees not to smoke, vape, or consume tobacco or other nicotine-containing products, not to consume alcohol, not to consume beverages containing caffeine or other xanthines.
- Is in good health based on the medical history, physical examination, vital signs measurements, laboratory tests, and 12-lead ECGs performed at screening.
Who cannot join
- Any condition that places the participant at significantly increased risk or may compromise the study objectives.
- Is mentally or legally incapacitated at screening.
- History of malignant neoplasms or carcinoma in situ.
- Has a current or chronic history of liver disease or known hepatic or biliary abnormalities.
- Has had symptomatic herpes zoster.
- Has a history of any known relevant allergy/hypersensitivity or intolerance.
Show all 21Show fewer
- Has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- Has a sensitivity to heparin or history of heparin-induced thrombocytopenia.
- Has a clinically significant infection.
- Any history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological.
- Has a clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study.
- Any clinically significant abnormality identified in the physical examination (including vital signs) or electrocardiographic testing.
- Has a positive test for the presence of human immunodeficiency virus (HIV), hepatitis C antibody, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of investigational product.
- Has active or latent tuberculosis (TB), regardless of treatment history, or positive diagnostic TB test at screening.
- Has received treatment with a live, attenuated vaccine within 4 weeks prior to the first dose of investigational product or anticipation of need for such a vaccine during study participation.
- Has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
- Has donated or lost blood or blood products in volumes of 450 mL or more within 30 days.
- Has had prior exposure to YUQ-A1007.
- Has participated in a study of any investigational drug, device, biologic, or other agent within 30 days or 5 half-lives prior to screening, whichever is longer.
- Has received any prescription medications, over-the-counter medications, herbal supplements, or vitamins within 30 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
- Is an employee or has a family member who is an employee of the CRU and is involved in the conduct of the study and/or supervised by the investigator; or is an employee or has a family member who is an employee of the sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral YUQ-A1007 in Healthy Volunteers
YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 has the potential to treat IBD.
YUQ-A1007 has not been evaluated in human clinical studies. This study is first-in-human (FIH) study of YUQ-A1007. The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.
- Conditions
- Healthy
- Being tested
- YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.
- Keywords
- Phase I, Randomized, Placebo-Controlled, Sequential Escalation, Safety, Tolerability, Pharmacokinetics, YUQ-A1007, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.Drug
Dose: Ascending doses (SAD stage: 200, 800, 1600, or 3200 mg; MAD stage: two dosages will be determined based on the results from the SAD stage) Mode of administration: Oral, once daily.
| Study group | Role | What they receive |
|---|---|---|
| SAD | Experimental | Single Ascending Dose Stage in Healthy Volunteers， 4 cohorts will be included Receives: Drug: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. |
| MAD | Experimental | Multiple Ascending Dose Stage in Healthy Volunteers, two dose levels will be included Receives: Drug: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of YUQ-A1007 administered orally
Number of participants with Treatment-emergent adverse events (TEAEs), with clinically significant changes from baseline in vital signs (body temperature, blood pressure, heart rate, and respiratory rate), physical examination findings, and 12-lead electrocardiogram (ECG) parameters, and with clinically significant changes from baseline in safety laboratory assessments (hematology, clinical chemistry, urinalysis, and stool routine test)
Measured: during the intervention (about 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835296
- Sponsor's protocol ID
- ATB102
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral YUQ-A1007 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06835296
- Acronym / sponsor ID
- ATB102
- Conditions
- Healthy
- Keywords
- Phase I, Randomized, Placebo-Controlled, Sequential Escalation, Safety, Tolerability, Pharmacokinetics, YUQ-A1007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 19 Feb 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.
YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 has the potential to treat IBD.
YUQ-A1007 has not been evaluated in human clinical studies. This study is first-in-human (FIH) study of YUQ-A1007. The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD | Experimental | Drug: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.Single Ascending Dose Stage in Healthy Volunteers， 4 cohorts will be included |
| MAD | Experimental | Drug: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.Multiple Ascending Dose Stage in Healthy Volunteers, two dose levels will be included |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent prior to the conduct of any study-related assessments.
- Aged 18 to 65 years, inclusive, at the time of signing the informed consent form (ICF).
- Male and Female participants.
- Has body mass index (BMI) as 18.5-27.9 kg/m2 with total body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants at screening.
- With normal liver and kidney functions.
Key exclusion criteria (21 listed)
- Any condition that places the participant at significantly increased risk or may compromise the study objectives.
- Is mentally or legally incapacitated at screening.
- History of malignant neoplasms or carcinoma in situ.
- Has a current or chronic history of liver disease or known hepatic or biliary abnormalities.
- Has had symptomatic herpes zoster.
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 |
|---|---|---|
| YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.Dose: Ascending doses (SAD stage: 200, 800, 1600, or 3200 mg; MAD stage: two dosages will be determined based on the results from the SAD stage) Mode of administration: Oral, once daily. | Drug | MAD, SAD |
Primary outcome
The safety and tolerability of YUQ-A1007 administered orally
Time frame: during the intervention (about 6 months)
Number of participants with Treatment-emergent adverse events (TEAEs), with clinically significant changes from baseline in vital signs (body temperature, blood pressure, heart rate, and respiratory rate), physical examination findings, and 12-lead electrocardiogram (ECG) parameters, and with clinically significant changes from baseline in safety laboratory assessments (hematology, clinical chemistry, urinalysis, and stool routine test)
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 26 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies. in people with Healthy, run by Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. at 1 site in United States.
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 9 inclusion and 21 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 26 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 United States. 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?
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?
The safety and tolerability of YUQ-A1007 administered orally (time frame: during the intervention (about 6 months)). 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 26 Dec 2025.