A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLeadingtac Pharmaceutical (Shaoxing) Co., Ltd.
About this trial
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. The effects of food on the pharmacokinetics of LT-002-158 will also be assessed in healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed consent form.
Disqualifiers
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, musculoskeletal, urinary, endocrine, neurologic disorders, psychiatric, and/ or any other conditions, judged by the Investigator, that would make the healthy volunteer unsuitable for this study.
Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn).
Trial design
Design model
Sequential
Treatments tested in this trial
LT-002-158/Placebo oral tablet(s)
DrugSingle ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Treatment groups
127 Participants
are divided into 3 treatment groupsGroup A: Single Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Food effectExperimental treatment 1 intervention
Group C: Multiple Ascending Doses (MAD) StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of LT-002-158 following single dose in HVs
Incidence and severity of treatment emergent Adverse Events
Time frame
up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov