GS3-007a dry suspension in healthy Chinese adults

A Phase I Clinical Study of GS3-007a Dry Suspensions in Healthy Chinese Adults: Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalation, and Food Effect Study

This trial will test single and multiple doses of GS3-007a dry suspension versus placebo in healthy Chinese adults to check safety, how the body processes it, and the effect of food.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07473570 on ClinicalTrials.gov

What this trial studies

This Phase I, randomized, double-blind, placebo-controlled, dose-escalation program enrolls healthy Chinese adults to characterize safety and pharmacokinetics. Part one is a single-ascending-dose (SAD) portion that includes a food-effect assessment, and part two is a 14-day multiple-ascending-dose (MAD) portion. Subjects are randomized to GS3-007a or placebo with blinded dosing and planned dose escalation based on safety and tolerability. The trial uses standard Phase I monitoring including ECGs, laboratory tests, and adverse event surveillance at a clinical site in Shanghai.

Who should consider this trial

Good fit: Healthy adults aged 18–45 years with BMI 19–26 kg/m² (males ≥50 kg, females ≥45 kg) who can consent and agree to reliable contraception are ideal candidates.

Not a fit: People with major allergies, a history of neurological or psychiatric disorders, abnormal ECG/QTc or liver tests, pregnant or planning conception, or those outside the age/weight/BMI limits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could show GS3-007a is safe and define dosing and food-effect information needed for later patient trials.

How similar studies have performed: Similar Phase I single- and multiple-dose studies of new oral agents are routinely used to establish safety and pharmacokinetics, but GS3-007a’s human data appear novel and limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
2. Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
3. Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures;
4. From screening day to 3 months after the last dose, have no plans for conception or sperm/egg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.).

Exclusion Criteria:

1. A highly allergic constitution
2. Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
3. Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.
4. Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
5. Individuals who are alcoholics or who regularly consumed alcohol within 6 months before the first dose of the trial, or those unwilling to stop drinking or consuming any alcohol-containing products during the entire trial.
6. Individuals with a history of heavy smoking or those who smoked an average of ≥5 cigarettes per day within the 3 months before screening
7. Individuals with immune deficiencies or immunosuppressive diseases, malignant tumors, chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive system diseases.
8. Individuals who underwent major surgery within 6 months before screening or during the screening period, or those who experienced acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months before screening;
9. Subjects who have donated blood (including blood components) within 3 months prior to the first dose, or have experienced blood loss ≥ 400 mL within 3 months prior to the first dose
10. Subjects who have participated in any clinical trial and used investigational drugs, vaccines, or devices within 3 months prior to screening
11. Subjects who have started a significantly abnormal diet within 4 weeks prior to screening or during the screening period, or have special dietary requirements, cannot comply with the standardized diet, or cannot tolerate the high-fat, high-calorie meal in postprandial trials
12. Female subjects who are pregnant or breastfeeding

Where this trial is running

Shanghai, Shanghai Municipality

• Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hong Xu

Conditions Healthy Adults