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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called YUQ-A1007, which might help with inflammatory bowel disease (IBD), a condition causing ongoing gut problems. The main goal is to determine the treatment's safety for humans and how the body processes it. The study involves healthy volunteers willing to take either a single dose or multiple doses. Ideal candidates are those in good health, with no significant medical issues, and who can stay at the research center for part of the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

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.

Is there any evidence suggesting that YUQ-A1007 is likely to be safe for humans?

Research shows that YUQ-A1007 has not yet been tested in humans. This trial is the first to assess its safety in people. As it is in an early stage, the main goal is to evaluate tolerance and identify any side effects.

Since YUQ-A1007 is new, no safety information from human studies exists yet. The trial aims to understand how the body processes the drug and whether it causes any issues. As a first-in-human study, safety remains the top priority. Healthy volunteers will receive the drug in varying doses to closely monitor their reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

YUQ-A1007 is unique because it is being tested on healthy volunteers to understand its safety and optimal dosing before targeting any specific condition. Unlike traditional treatments, which might already be focused on specific diseases, YUQ-A1007 is in its early phase of testing, exploring both single and multiple ascending doses to establish a safe profile. Researchers are excited because this approach can reveal the drug's potential to address underlying mechanisms before moving on to treat actual conditions, possibly leading to more effective and safer therapies in the future.

What evidence suggests that YUQ-A1007 might be an effective treatment for IBD?

Research shows that YUQ-A1007 is a new type of medicine that works in the gut, targeting a specific part involved in immune responses. Early animal studies have shown promise for YUQ-A1007 in treating inflammatory bowel disease (IBD) by affecting these immune pathways. Although it has not been tested in humans yet, its mechanism suggests potential in managing gut inflammation. This first human trial will assess its safety and how the body processes it, with participants receiving either a Single Ascending Dose (SAD) or a Multiple Ascending Dose (MAD) of YUQ-A1007. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06835296

A Study of Oral YUQ-A1007 in Healthy Volunteers The goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics of oral YUQ-A1007.

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-3aa1b

YUQ-A1007 for Healthy Volunteers YUQ-A1007 is unique because it is a compound of traditional Chinese herbal medicine, which may offer a novel approach compared to conventional treatments.

3. policylab.us policylab.us/clinical-trials/l/california?page=273

California Paid Clinical Trials - Policy Lab 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 ...

4. synapse.patsnap.com synapse.patsnap.com/organization/0063cded275aed2d1277554cd134be8b

Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. ... Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral YUQ-A1007 in Healthy Volunteers. 100 Clinical Results associated with Allianthera ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0059969

Healthy Lifestyle Behaviors (DBCOND0059969) A Study of Oral YUQ-A1007 in Healthy Volunteers. YUQ-A1007. treatment, 1, recruiting. NCT00821496. Evaluate the Effect of VI-0521 on the Pharmacokinetics of ...

6. synapse.patsnap.com synapse.patsnap.com/drug/bacb0a7d9baf4b0b80601a427daed944

YUQA-1007 - Drug Targets, Indications, Patents ... Safety, Tolerability, and Pharmacokinetics of Oral YUQ-A1007 in Healthy Volunteers. 100 Clinical Results associated with YUQA-1007. Login to view more data.

7. ctv.veeva.com ctv.veeva.com/site/cenexel-clinical-research-anaheim-clinical-trials

CenExel Clinical Research | Anaheim Clinical Trials A Study of Oral YUQ-A1007 in Healthy Volunteers. YUQ-A1007 is a novel gut-enriched AhR agonist. The nonclinical pharmacology study indicated that YUQ-A1007 ...