NCT05942625

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

July 4, 2023

Last Update Submit

October 7, 2024

Conditions

IgA NephropathyFocal Segmental Glomerulosclerosis

Keywords

HS-10390SafetyTolerabilityPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (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 28 (MAD)

Secondary Outcomes (7)

  • Maximum plasma concentration (Cmax)

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

  • Time to reach Cmax (Tmax)

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

  • Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

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

  • Half time (t½)

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

  • Apparent clearance (CL/F)

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

  • +2 more secondary outcomes

Study Arms (2)

HS-10390

EXPERIMENTAL

Single or multiple dosing of HS-10390 in a fastingstate

Drug: HS-10390 tablet

Placebo

EXPERIMENTAL

Single or multiple dosing of placebo in a fastingstate

Drug: Placebo tablet

Interventions

HS-10390 tabletDRUG

Oral administration of specified dose of HS-10390

HS-10390
Placebo tabletDRUG

Oral administration of matching dose ofplacebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
  • Have signed the informed consent form approved by the IRB

You may not qualify if:

  • History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
  • Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, 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 ordrugs of abuse
  • Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
  • Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
  • Pregnant or breastfeeding female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGAGlomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Bicheng Liu

CONTACT

18001580838liubc64@163.com

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

July 4, 2023

First Posted

July 12, 2023

Study Start

May 23, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

CN(1)