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

NCT06033742 | Completed Phase 1

• 1 other identifier: HS-10374-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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)

• Number of participants with clinical laboratory abnormalities

  Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.

  Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)

• 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)

• 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)

• 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 Outcomes (7)

• Cmax

  Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

• Tmax

  Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

• AUC

  Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

• t½

  Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

• CL/F

  Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)

Study Arms (2)

HS-10374

EXPERIMENTAL

Single and multiple ascending doses of HS-10374 orally

Drug: HS-10374 tablets

Placebo

PLACEBO COMPARATOR

Single and multiple ascending doses of HS-10374-matched placebo orally

Drug: HS-10374-matched placebo tablets

Interventions

HS-10374 tablets DRUG

Single or multiple dosing of HS-10374 orally in a fasting state

HS-10374

HS-10374-matched placebo tablets DRUG

Single or multiple dosing of HS-10374-matched placebo orally in a fasting state

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects between the ages of 18-45 years
• 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
• Have signed the informed consent form approved by the IRB

You may not qualify if:

• 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
• Have a history of or current allergic disease
• Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
• Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
• Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
• Pregnant or breastfeeding female subjects
• 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Zhang, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Jinhua Xu, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 13, 2023
• Study Start: November 13, 2021
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-08

Locations

CN (1)