Clinical trial NCT06033742: A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects between the ages of 18-45 years
2. Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
3. Have signed the informed consent form approved by the IRB

Exclusion Criteria:

1. Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis
2. Have a history of or current allergic disease
3. Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
4. Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
5. Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
6. Pregnant or breastfeeding female subjects
7. Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period

Primary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
measure: Number of participants with abnormalities of vital signs
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
measure: Number of participants with abnormalities of physical examination
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
measure: Number of participants with abnormalities of electrocardiogram (ECG) parameters
timeFrame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Secondary outcomes:
measure: Cmax
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Tmax
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: AUC
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: t½
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: CL/F
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Vz/F
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
measure: Rac
timeFrame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Jinhua Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: