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

NCT07522970 | Not Yet Recruiting Phase 1

• 1 other identifier: LG-0317-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

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

  Day 1 to day 18

• Number of participants with clinically significant laboratory assessment abnormalities

  Day 1 to day 18

• Number of participants with clinically significant Vital sign abnormalities

  Day 1 to day 18

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

  Day 1 to day 18

• Number of participants with clinically significant physical examination abnormalities

  Day 1 to day 18

Study Arms (2)

LG-0317

EXPERIMENTAL

Drug: LG-0317

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LG-0317 DRUG

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

LG-0317

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LinGang Laboratory: lead

Central Study Contacts

Translational Clinical Group officer

CONTACT

021-64220292; feng.wang@lglab.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04