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RecruitingNCT07522970Updated Jun 25, 2026

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants

A Phase 1 interventional study of LG-0317 and Placebo in Healthy Volunteers, sponsored by LinGang Laboratory. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by LinGang Laboratory · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

LinGang Laboratory is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    LG-0317

    Drug: LG-0317

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugLG-0317

    Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

  • DrugPlacebo

    Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

06

What researchers measure

Primary outcomes

  1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 to day 18

  2. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: Day 1 to day 18

  3. Number of participants with clinically significant Vital sign abnormalities

    Time frame: Day 1 to day 18

  4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: Day 1 to day 18

  5. Number of participants with clinically significant physical examination abnormalities

    Time frame: Day 1 to day 18

07

Study locations

1 of 1 sites recruiting
  • Shanghai Xuhui Central Hospital
    Shanghai, Shanghai Municipality 200237, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07522970
Lead sponsor
LinGang Laboratory
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Apr 20, 2026
Primary completion
Sep 10, 2026 (estimated)
Completion
Sep 10, 2026 (estimated)
Last update
Jun 25, 2026

Study contacts

Translational Clinical Group officer
Contact
feng.wang@lglab.ac.cn
021-64220292

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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