Healthy SubjectPhase 1NCT05611281
GS3-007a Oral Solution in Healthy Subjects
A Phase 1 study of Healthy Subject, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2022to 1 Apr 2023
- 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
- Healthy adult subjects aged 18-45 years (including boundary values), male and female;
- Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;
Who cannot join
- Patients with a history of substance abuse and substance dependence;
- Family history of sudden death;
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
Chengdu, Chengdu, 610000
About this study
Official title: Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
Read the detailed description
This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended
- Conditions
- Healthy Subject
- Being tested
- GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medicationDrug
The dosage was calculated according to body weight and dose group once a day according to the assigned group.
| Study group | Role | What they receive |
|---|---|---|
| GS3-007 oral liquid | Experimental | 78 subjects: Part 1 SAD 36 subjects: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.
Part 2 MAD 30 subjects: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Part 3 Food effects 12 subjects: Planned in 1.6mg/kg dose group。Once a day, a total of one dose. Receives: Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication |
| Placebo GS3-007 oral liquid | Placebo comparator | Part 1 SAD: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.
Part 2 MAD: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Receives: Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
Measured: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;
Secondary outcomes (1)
PK characteristics
To evaluate the pharmacokinetic (Peak Plasma Concentration (Cmax)) characteristics of GS3-007A in Chinese healthy adults after single, multiple, and single oral administration of high-fat meals.
Measured: Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start22 Sep 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 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
- NCT05611281
- Sponsor's protocol ID
- GenSci073-101
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 11 Apr 2023
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
- ClinicalTrials.gov ID
- NCT05611281
- Acronym / sponsor ID
- GenSci073-101
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 10 Nov 2022 (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.
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
Detailed description
This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS3-007 oral liquid | Experimental | Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication78 subjects: Part 1 SAD 36 subjects: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose. Part 2 MAD 30 subjects: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Part 3 Food effects 12 subjects: Planned in 1.6mg/kg dose group。Once a day, a total of one dose. |
| Placebo GS3-007 oral liquid | Placebo comparator | Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medicationPart 1 SAD: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose. Part 2 MAD: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult subjects aged 18-45 years (including boundary values), male and female;
- Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;
Key exclusion criteria (2 listed)
- Patients with a history of substance abuse and substance dependence;
- Family history of sudden death;
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 |
|---|---|---|
| GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medicationThe dosage was calculated according to body weight and dose group once a day according to the assigned group. | Drug | GS3-007 oral liquid, Placebo GS3-007 oral liquid |
Primary outcome
TEAEs
Time frame: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;
Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
1 secondary outcome
PK characteristics
Time frame: Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;
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 11 Apr 2023.
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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 of Healthy Subject, 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 2 inclusion and 2 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 11 Apr 2023. 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?
TEAEs (time frame: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;). 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 11 Apr 2023.