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

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06033742
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.3
• Patients Per Site Per Month: 5.2

Study Details

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
• 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: Nov 13, 2021
• Actual Primary Completion Date: Mar 24, 2023
• Actual Study Completion Date: Mar 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 [Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)]

2. Number of participants with clinical laboratory abnormalities [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 [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 [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 [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 [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Maximum plasma concentration

2. Tmax [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Time to reach Cmax

3. AUC [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Area under the plasma concentration-time curve

4. t½ [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Terminal half-life

5. CL/F [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Apparent clearance

6. Vz/F [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Apparent volume of distribution

7. Rac [Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)]

   Accumulation ratio

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06033742
• Other Study ID Numbers: HS-10374-101
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Sep 13, 2023