Healthy VolunteersPhase 1NCT07522970
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants
A Phase 1 study testing LG-0317 in people with Healthy Volunteers, run by LinGang Laboratory at 1 site in China.
Trial summary
This study is the first administration of LG-0317 to humans. The purpose of the study is to evaluate safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept 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 Volunteers
- What is being tested?
- LG-0317
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 10 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 male and female subjects age 18 to 45 years of age included.
- Participant must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18-32 kg/m2 inclusive.
- The participant has normal results or abnormalities without clinical significance as judged by the investigator for vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), 12-lead electrocardiogram (ECG).
- Fully understand the trial content, procedures, and possible adverse reactions; voluntarily participate and sign the informed consent form (ICF).
- Able to communicate well with the study personnel, and understand and comply with the relevant requirements of the trial.
Who cannot join
- History of allergic diseases, or known allergy to the investigational product, its excipients, or related products.
- History of significant cardiovascular, respiratory, renal, neurological disease.
- History of psychiatric disorders, substance abuse, or drug dependence.
- Suicidal risk according to the Columbia-Suicide Severity Rating Scale (C-SSRS) or based on the investigator's clinical judgment, or history of self-injurious behavior.
- Smoking ≥5 cigarettes per day within 3 months prior to screening.
- Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements within 14 days prior to the first dose.
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- Participation in another clinical trial and receipt of an investigational drug within 3 months prior to the first dose.
- Blood donation or significant blood loss (>400 mL) or blood transfusion within 3 months prior to the first dose.
- Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant.
- Pregnant or lactating females or subjects (including males) planning to father a child during the trial or within 3 months after the last dose, unwillingness to use effective non-pharmacological contraception during the trial period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200237
Qian Chen, Doctor, 021-64220292, zryyec@126.com
About this study
Official title: A Randomized, Single and Multiple Ascending Doses, Food-effect Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 Tablets in Healthy Chinese Participants
This study is the first administration of LG-0317 to humans. The purpose of the study is to evaluate safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies.
Read the detailed description
This study consists of three parts: single ascending dose, food effect , and multiple ascending dose. The single ascending dose part consists of a screening period (4 weeks), a dosing observation period and a follow-up period. Participants in different dose groups will be enrolled sequentially according to the dose escalation principle. In the food effect part, eligible participants will be randomly assigned to Sequence 1 or Sequence 2 prior to dosing in the first period. Participants will receive a single oral dose of LG-0317 tablet either under fasting conditions or after a high-fat, high-calorie meal, depending on their assigned sequence. The multiple ascending dose part will include 3-4 dose groups, and the dose levels will be determined based on the safety, tolerability, and available PK and PD data obtained from the single ascending dose part.
- Conditions
- Healthy Volunteers
- Being tested
- LG-0317, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG-0317Drug
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
PlaceboDrug
Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
| Study group | Role | What they receive |
|---|---|---|
| LG-0317 | Experimental | Not described Receives: Drug: LG-0317 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 to day 18
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Day 1 to day 18
Number of participants with clinically significant Vital sign abnormalities
Measured: Day 1 to day 18
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Day 1 to day 18
Number of participants with clinically significant physical examination abnormalities
Measured: Day 1 to day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Model description
- Study drug: LG-0317 and placebo. In the single ascending dose part, subjects will be randomized and dosed in different cohorts with a single dose. In the multiple ascending dose part, subjects will be randomized and dosed in different cohorts with multiple doses.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LinGang Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522970
- Sponsor's protocol ID
- LG-0317-01
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 25 Jun 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single and Multiple Ascending Doses, Food-effect Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 Tablets in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07522970
- Acronym / sponsor ID
- LG-0317-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LinGang LaboratoryUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 13 Apr 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 is the first administration of LG-0317 to humans. The purpose of the study is to evaluate safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies.
Detailed description
This study consists of three parts: single ascending dose, food effect , and multiple ascending dose. The single ascending dose part consists of a screening period (4 weeks), a dosing observation period and a follow-up period. Participants in different dose groups will be enrolled sequentially according to the dose escalation principle. In the food effect part, eligible participants will be randomly assigned to Sequence 1 or Sequence 2 prior to dosing in the first period. Participants will receive a single oral dose of LG-0317 tablet either under fasting conditions or after a high-fat, high-calorie meal, depending on their assigned sequence. The multiple ascending dose part will include 3-4 dose groups, and the dose levels will be determined based on the safety, tolerability, and available PK and PD data obtained from the single ascending dose part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study drug: LG-0317 and placebo. In the single ascending dose part, subjects will be randomized and dosed in different cohorts with a single dose. In the multiple ascending dose part, subjects will be randomized and dosed in different cohorts with multiple doses.
| Arm | Type | Receives |
|---|---|---|
| LG-0317 | Experimental | Drug: LG-0317 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female subjects age 18 to 45 years of age included.
- Participant must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18-32 kg/m2 inclusive.
- The participant has normal results or abnormalities without clinical significance as judged by the investigator for vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), 12-lead electrocardiogram (ECG).
- Fully understand the trial content, procedures, and possible adverse reactions; voluntarily participate and sign the informed consent form (ICF).
- Able to communicate well with the study personnel, and understand and comply with the relevant requirements of the trial.
Key exclusion criteria (11 listed)
- History of allergic diseases, or known allergy to the investigational product, its excipients, or related products.
- History of significant cardiovascular, respiratory, renal, neurological disease.
- History of psychiatric disorders, substance abuse, or drug dependence.
- Suicidal risk according to the Columbia-Suicide Severity Rating Scale (C-SSRS) or based on the investigator's clinical judgment, or history of self-injurious behavior.
- Smoking ≥5 cigarettes per day within 3 months prior to screening.
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 |
|---|---|---|
| LG-0317Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses | Drug | LG-0317 |
| PlaceboSubjects are planned to be dosed in oral tablet, with single and multiple ascending doses | Drug | Placebo |
Primary outcome
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to day 18
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant Vital sign abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Day 1 to day 18
Number of participants with clinically significant physical examination abnormalities
Time frame: Day 1 to day 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Screening Protocol
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.
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 LG-0317 in people with Healthy Volunteers, run by LinGang Laboratory 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 25 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Translational Clinical Group officer (021-64220292, feng.wang@lglab.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 to day 18). The study lists 5 primary outcomes in all. 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 25 Jun 2026.