Healthy AdultsPhase 1NCT07473570
A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
A Phase 1 study testing GS3-007a for Suspension in people with Healthy Adults, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- GS3-007a for Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 4 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
- Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
- 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;
- 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.).
Who cannot join
- A highly allergic constitution
- Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
- 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.
- Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
- 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.
- Individuals with a history of heavy smoking or those who smoked an average of ≥5 cigarettes per day within the 3 months before screening
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- Individuals with immune deficiencies or immunosuppressive diseases, malignant tumors, chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive system diseases.
- 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;
- 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
- Subjects who have participated in any clinical trial and used investigational drugs, vaccines, or devices within 3 months prior to screening
- 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
- Female subjects who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200233
About this study
Official title: 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 study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.
- Conditions
- Healthy Adults
- Being tested
- GS3-007a for Suspension, Placebo GS3-007a for Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS3-007a for SuspensionDrug
GS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C.
Placebo GS3-007a for SuspensionDrug
Placebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug.
| Study group | Role | What they receive |
|---|---|---|
| GS3-007a- dose level 1 (SAD/FE) | Experimental | Not described Receives: Drug: GS3-007a for Suspension |
| GS3-007a- dose level 2 (SAD/FE) | Experimental | Not described Receives: Drug: GS3-007a for Suspension |
| Placebo (SAD/FE) | Placebo comparator | Not described Receives: Drug: Placebo GS3-007a for Suspension |
| GS3-007a- dose level 1 (MAD) | Experimental | Not described Receives: Drug: GS3-007a for Suspension |
| GS3-007a- dose level 2 (MAD) | Experimental | Not described Receives: Drug: GS3-007a for Suspension |
| Placebo (MAD) | Placebo comparator | Not described Receives: Drug: Placebo GS3-007a for Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: up to 6 days (SAD+FE phase), up to 21 days (MAD)
Secondary outcomes (10)
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax)
Measured: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax)
Measured: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Measured: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)
Measured: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max)
Measured: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max)
Measured: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min)
Measured: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av)
Measured: up to 21 days (MAD)
Pharmacodynamics(PD) Indicators
Measured: up to 6 days (SAD+FE phase), up to 21 days (MAD)
PD Indicators
Measured: The entire MAD research phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start7 Jan 2026
- Primary completion6 May 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473570
- Sponsor's protocol ID
- GenSci073-107
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07473570
- Acronym / sponsor ID
- GenSci073-107
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GS3-007a- dose level 1 (SAD/FE) | Experimental | Drug: GS3-007a for Suspension |
| GS3-007a- dose level 2 (SAD/FE) | Experimental | Drug: GS3-007a for Suspension |
| Placebo (SAD/FE) | Placebo comparator | Drug: Placebo GS3-007a for Suspension |
| GS3-007a- dose level 1 (MAD) | Experimental | Drug: GS3-007a for Suspension |
| GS3-007a- dose level 2 (MAD) | Experimental | Drug: GS3-007a for Suspension |
| Placebo (MAD) | Placebo comparator | Drug: Placebo GS3-007a for Suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
- Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
- 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;
- 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.).
Key exclusion criteria (12 listed)
- A highly allergic constitution
- Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
- 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.
- Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS3-007a for SuspensionGS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C. | Drug | GS3-007a- dose level 1 (MAD), GS3-007a- dose level 1 (SAD/FE), GS3-007a- dose level 2 (MAD), GS3-007a- dose level 2 (SAD/FE) |
| Placebo GS3-007a for SuspensionPlacebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug. | Drug | Placebo (MAD), Placebo (SAD/FE) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 6 days (SAD+FE phase), up to 21 days (MAD)
10 secondary outcomes
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av)
Time frame: up to 21 days (MAD)
Pharmacodynamics(PD) Indicators
Time frame: up to 6 days (SAD+FE phase), up to 21 days (MAD)
PD Indicators
Time frame: The entire MAD research phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS3-007a for Suspension in people with Healthy Adults, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: up to 6 days (SAD+FE phase), up to 21 days (MAD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.