Healthy SubjectPhase 1NCT05921890
To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.
A Phase 1 study testing GS3-007 oral liquid in people with 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 oral solution after multiple oral administration in Chinese healthy adult subjects. 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
- What is being tested?
- GS3-007 oral liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 28 Oct 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 or female;
- Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;
Who cannot join
- (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
- (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
- ALT and AST exceed the upper limit of the normal range;
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
Chengdu, Sichuan, 610000
About this study
Official title: To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.
To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.
Read the detailed description
To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects
- Conditions
- Healthy Subject
- Being tested
- GS3-007 oral liquid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS3-007 oral liquidDrug
The dosage was calculated according to body weight, once a day or twice a day.
| Study group | Role | What they receive |
|---|---|---|
| GS3-007 oral liquid | Experimental | 36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks. Receives: Drug: GS3-007 oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Measured: 35 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start19 Jun 2023
- Primary completion28 Oct 2023
- Study completion28 Oct 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05921890
- Sponsor's protocol ID
- GenSci073-104
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.
- ClinicalTrials.gov ID
- NCT05921890
- Acronym / sponsor ID
- GenSci073-104
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 27 Jun 2023 (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 oral solution after multiple oral administration in Chinese healthy adult subjects.
Detailed description
To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GS3-007 oral liquid | Experimental | Drug: GS3-007 oral liquid36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks. |
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 or female;
- Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;
Key exclusion criteria (3 listed)
- (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
- (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
- ALT and AST exceed the upper limit of the normal range;
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 liquidThe dosage was calculated according to body weight, once a day or twice a day. | Drug | GS3-007 oral liquid |
Primary outcome
TEAEs
Time frame: 35 Days
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 9 Nov 2023.
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Pain
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 GS3-007 oral liquid in people with 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 3 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 9 Nov 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. 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: 35 Days). 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 9 Nov 2023.