YUQ-A1007 for Healthy Volunteers

Overseen By Michelle Haynes

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.

Must not be taking: Prescription medications

Disqualifiers: Liver disease, HIV, TB, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications, over-the-counter medications, herbal supplements, or vitamins at least 30 days before the first dose of the study drug.

How is the drug YUQ-A1007 different from other treatments?

YUQ-A1007 is unique because it is a compound of traditional Chinese herbal medicine, which may offer a novel approach compared to conventional treatments. While specific details about YUQ-A1007 are not provided, similar herbal compounds have shown potential in improving conditions like insulin resistance and glucose metabolism in animal studies. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy men and women aged 18-65 with a BMI of 18.5-27.9 kg/m2, weighing at least 50 kg (men) or 45 kg (women). Participants must be in good health as determined by medical history, exams, and tests including ECGs. They should agree to stay at the study site when required and not use tobacco, alcohol, or caffeine.

Inclusion Criteria

Written informed consent prior to the conduct of any study-related assessments

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

Exclusion Criteria

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

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

Any condition that places the participant at significantly increased risk or may compromise the study objectives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of YUQ-A1007 to evaluate safety and pharmacokinetics

6 months

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of YUQ-A1007 to further evaluate safety and pharmacokinetics

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• YUQ-A1007

Trial Overview The trial is testing YUQ-A1007, an experimental drug designed to treat IBD by targeting the gut. This first-in-human study will assess its safety, how well it's tolerated by the body, and how it's processed after being taken orally.

Participant Groups

Group I: SAD Experimental Treatment 1 Intervention

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

Group II: MAD Experimental Treatment 1 Intervention

Multiple Ascending Dose Stage in Healthy Volunteers, two dose levels will be included

Who Is Running the Clinical Trial?

Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

1

Recruited

50+

References

1. Singapore pubmed.ncbi.nlm.nih.gov

The protective effect of Yi-Qi-Yang-Yin-Ye, a compound of traditional Chinese herbal medicine in diet-induced obese rats. [2011]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Elucidating the pharmacodynamic mechanisms of Yuquan pill in T2DM rats through comprehensive multi-omics analyses. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Yan-Hou-Qing formula attenuates allergic airway inflammation via up-regulation of Treg and suppressing Th2 responses in Ovalbumin-induced asthmatic mice. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Effects of Liuwei Dihuang Decoction (Yukmijihwang-tang) on Physical Fatigue by Regulating Neurotransmitters in Brain. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Yiqi Huazhuo decoction increases insulin secretion in type 2 diabetic rats by regulating the pancreatic GPR40-IP3R-1 signaling pathway. [2023]