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

• ClinicalTrials.gov Identifier: NCT06033742
• Recruitment Status: Completed
• First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: HS-10374 tablets; Drug: HS-10374-matched placebo tablets	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 13, 2021
• Actual Primary Completion Date: March 24, 2023
• Actual Study Completion Date: March 24, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: HS-10374; Single and multiple ascending doses of HS-10374 orally	Drug: HS-10374 tablets; Single or multiple dosing of HS-10374 orally in a fasting state
Placebo Comparator: Placebo; Single and multiple ascending doses of HS-10374-matched placebo orally	Drug: HS-10374-matched placebo tablets; Single or multiple dosing of HS-10374-matched placebo orally in a fasting state

Outcome Measures

Primary Outcome Measures :

1. Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [ Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) ]
2. Number of participants with clinical laboratory abnormalities [ Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) ]
   Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
3. Number of participants with abnormalities of vital signs [ Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) ]
   Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
4. Number of participants with abnormalities of physical examination [ Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) ]
   Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
5. Number of participants with abnormalities of electrocardiogram (ECG) parameters [ Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) ]
   ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

Secondary Outcome Measures :

1. Cmax [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Maximum plasma concentration
2. Tmax [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Time to reach Cmax
3. AUC [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Area under the plasma concentration-time curve
4. t½ [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Terminal half-life
5. CL/F [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Apparent clearance
6. Vz/F [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Apparent volume of distribution
7. Rac [ Time Frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) ]
   Accumulation ratio

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

China, Shanghai

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai, China, 200040

Sponsors and Collaborators

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Jing Zhang, PhD; Huashan Hospital
• Principal Investigator: Jinhua Xu, MD; Huashan Hospital

More Information

• Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06033742
• Other Study ID Numbers: HS-10374-101
• First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases