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Official title A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT06082323
What this study is testing
- What it's testing
- LT-002-158 is an oral IRAK4 protein degrader being developed for the treatment of autoimmune disease and inflammation including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of LT-002-158 in healthy volunteers.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 1) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed...
- 2) Male or female between 18 and 55 years of age (inclusive), at the time of signing the informed consent form.
- 3) Body mass index (BMI) range within 18\~30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female.
- 4) Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test on Day -2 (admission).
- 5) Healthy volunteers with no significant medical history judged by the Investigator and in good health, fully physical examinations, vital signs...
You likely can't join if
- Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, or are allergic to any component of the IP considered clinically...
- Healthy volunteers who are vegans or have medical dietary restrictions.
- Healthy volunteers with clinically relevant history of respiratory, immunological, dermatological, connective tissue, lymphatic, metabolism, hepatic...
- Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn).
- Healthy volunteers who have an acute infection such as influenza at screening or admission.
- Healthy volunteers who have increased risk of infection.
See the full eligibility criteria
- 1) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed consent form.
- 2) Male or female between 18 and 55 years of age (inclusive), at the time of signing the informed consent form.
- 3) Body mass index (BMI) range within 18\~30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female.
- 4) Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test on Day -2 (admission).
- 5) Healthy volunteers with no significant medical history judged by the Investigator and in good health, fully physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests...
- 6) Females must be non- pregnant, non- lactating and must have negative serum pregnancy test at screening. Women of child bearing potential and males must be willing to use highly effective acceptable forms of...
- 7) All HVs who must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, or are allergic to any component of the IP considered clinically significant in the Investigator's judgment.
- Healthy volunteers who are vegans or have medical dietary restrictions.
- Healthy volunteers with clinically relevant history of respiratory, immunological, dermatological, connective tissue, lymphatic, metabolism, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal...
- Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn).
- Healthy volunteers who have an acute infection such as influenza at screening or admission.
- Healthy volunteers who have increased risk of infection.
- With history and/or presence of tuberculosis; positive result for IFN-γ release assay (IGRA) (i.e., QuantiFERON TB-Gold), the test may be repeated if the initial test result is indeterminate. Volunteers who have resided...
- HV who engage in high risk unsafe sexual practices.
- With active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma.
- With a disease history suggesting abnormal immune function.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.