A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06033742
• Other study ID #: HS-10374-101
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2021
• Est. completion date: March 24, 2023

Study information

• Verified date: August 2023
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• HS-10374 tablets
Single or multiple dosing of HS-10374 orally in a fasting state
• HS-10374-matched placebo tablets
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation		Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Primary	Number of participants with clinical laboratory abnormalities	Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine ß2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.	Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Primary	Number of participants with abnormalities of vital signs	Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.	Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Primary	Number of participants with abnormalities of physical examination	Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.	Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Primary	Number of participants with abnormalities of electrocardiogram (ECG) parameters	ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.	Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Secondary	Cmax	Maximum plasma concentration	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Tmax	Time to reach Cmax	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	AUC	Area under the plasma concentration-time curve	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	t½	Terminal half-life	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	CL/F	Apparent clearance	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Vz/F	Apparent volume of distribution	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Secondary	Rac	Accumulation ratio	Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)