Phase
Condition
Allergy
Rash
Acne Inversa
Treatment
LT-002-158/Placebo oral tablet(s)
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy volunteers who fully understand the content, process, and possibleadverse event of the study and capable of giving written informed consent form.
Male or female between 18 and 55 years of age (inclusive), at the time ofsigning the informed consent form.
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.
Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test onDay -2 (admission).
Healthy volunteers with no significant medical history judged by theInvestigator and in good health, fully physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests (hematology,urinalysis, blood chemistry and coagulation test), serum virology test.
Females must be non- pregnant, non- lactating and must have negative serumpregnancy test at screening. Women of child bearing potential and males must bewilling to use highly effective acceptable forms of contraception fromscreening to 6 months after the last study drug administration. Males andfemales must be willing to avoid donating sperm or egg respectively during thestudy period and 6 months after the last dose of IP.
All HVs who must be willing and able to comply with scheduled visits, treatmentplan, laboratory tests, and other study procedures.
Exclusion
Exclusion Criteria:
Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, orare allergic to any component of the IP considered clinically significant in theInvestigator'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, musculoskeletal, urinary,endocrine, neurologic disorders, psychiatric, and/ or any other conditions, judgedby the Investigator, that would make the healthy volunteer unsuitable for thisstudy.
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 oradmission.
Healthy volunteers who have increased risk of infection.
With history and/or presence of tuberculosis; positive result for IFN-γ releaseassay (IGRA) (i.e., QuantiFERON TB-Gold), the test may be repeated if theinitial test result is indeterminate. Volunteers who have resided in regionswhere tuberculosis or mycosis are endemic during 90 days before screening orwho intend to visit such a region during the duration of the study.
HV who engage in high risk unsafe sexual practices.
With active malignancy or neoplastic disease in the previous 5 years other thansuperficial basal cell carcinoma.
With a disease history suggesting abnormal immune function.
Study Design
Study Description
Connect with a study center
Shanghai Xuhui Distric Central Hospital
Shanghai, 200031
ChinaActive - Recruiting

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