A Study of Oral YUQ-A1007 in Healthy Volunteers

NCT06835296 | Completed Phase 1 FDA Drug

• 1 other identifier: ATB102
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.

Conditions

Healthy

Keywords

Phase I; Randomized; Placebo-Controlled; Sequential Escalation; Safety; Tolerability; Pharmacokinetics; YUQ-A1007; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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)

  during the intervention (about 6 months)

Study Arms (2)

SAD

EXPERIMENTAL

Single Ascending Dose Stage in Healthy Volunteers， 4 cohorts will be included

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

Drug: YUQ-A1007 is a novel gut-enriched AhR agonist. This compound is undergoing preclinical development, and comprehensive nonclinical studies.

Interventions

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.

MAD; SAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: February 19, 2025
• Study Start: March 20, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)