Actively Recruiting

Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT05942625

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

Led by Hansoh BioMedical R&D Company · Updated on 2024-10-09

84

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

CONDITIONS

Official Title

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • History or evidence of significant cardiovascular, pulmonary, endocrine, gastrointestinal, psychiatric, neurologic, hematological, or metabolic diseases that interfere with drug absorption, metabolism, or excretion
  • Current or recent (past 30 days) clinically significant infection, history of active tuberculosis, or positive screening for infectious diseases including tuberculosis, viral hepatitis, AIDS, or syphilis
  • History of or current allergic disease
  • History of drug or alcohol abuse or positive test results for alcohol or drugs of abuse
  • Smoking 5 or more cigarettes per day within past 3 months or positive test for nicotine
  • Clinically significant abnormal physical exam, vital signs, lab values, ECGs, or imaging tests
  • Pregnant or breastfeeding female subjects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

B

Bicheng Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects | DecenTrialz