Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

Phase IRandomizedPlacebo-ControlledSequential EscalationSafetyTolerabilityPharmacokineticsYUQ-A1007Healthy 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.

MADSAD

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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).

Sponsors & Collaborators

Allianthera (Suzhou) Biopharmaceuticals Co., Ltd.
Industrylead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Enrollment

47 participants (actual enrollment reported by the registry).

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

Actual (reported)

A Study of Oral YUQ-A1007 in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

SAD

MAD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

SAD

MAD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations