A Phase 1 Study of KHN702 Tablets in Healthy Subjects

NCT07044960 | Not Yet Recruiting Phase 1

• 1 other identifier: KHN702-30101
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events (AEs)

  Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.

  From screening to Day 4 for Part 1, and Day 10 for Part 2.

Secondary Outcomes (7)

• Maximum observed plasma concentration (Cmax)

  Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

• Time to reach maximum observed concentration (Tmax)

  Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

• Area under plasma concentration-time curve from zero to infinity (AUC0-inf)

  Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

• Area under the plasma concentration-curve across the dosing interval (AUC0-tau)

  Day 1 to Day 10.

• Terminal elimination half-life (t1/2)

  Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

Study Arms (2)

KHN702 tablet-Part I

EXPERIMENTAL

All participants will receive single dose of KHN702 tablet or placebo.

Drug: KHN702 tablet or placebo

KHN702 tablet-Part II

EXPERIMENTAL

All participants will receive mutiple doses of KHN702 tablet or placebo.

Drug: KHN702 tablet or placebo

Interventions

KHN702 tablet or placebo DRUG

Subject will receive a single KHN702 tablet or matching placebo orally in fasted state.

KHN702 tablet-Part I

Eligibility Criteria

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

You may qualify if:

• Age: 18 to 45 years old (inclusive), Male or female. 2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19\~26 kg/m2 (inclusive).
• \. Effective contraception measures and no sperm/egg donation plan from signing the informed consent to 3 months after last dose.

You may not qualify if:

• Have clinically significant medical history or clinical manifestations, including but not limited to the history of any clinically serious disease such as hematological system, circulatory system,digestive system, urinary system, respiratory system, central nervous system,immunology, endocrine system cardiovascular system, malignant tumors, metabolic abnormalities, or any other disease or physiological condition that may interfere with the results .
• Subjects with clinically significant abnormalities in vital signs, physical examination, 12 lead electrocardiogram, laboratory examination, abdominal color Doppler ultrasound and chest X-ray during screening period, as determined by the investigator.
• Dysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.
• Had surgery within 3 months before screening, or planned surgery during the study period, or had surgery that would affect drug absorption, distribution, metabolism, and excretion.
• Allergic to the IMP or its excipients, or allergic to two or more other drugs, food and environment, or prone to skin rash, urticaria and other allergic symptoms.
• Allergic to natural light / UV, or phototoxic reaction after previous use of specific drugs (such as fluoroquinolones and tetracyclines).
• There are risk factors for cardiac disease, including but not limited to congenital long QT syndrome, torsade de pointes or torsade de pointes (such as hypokalemia, hypomagnesemia, family history of long QT syndrome). Currently, class IA \[such as quinidine or procainamide\] or class III \[such as amiodarone or sotalol\] antiarrhythmic drugs or other drugs known to affect QT interval are used. Or QTc interval (QTCF) corrected according to fridericia's criteria \> 450 ms in males and \> 470 ms in females at screening or other 12 lead ECG abnormalities with clinical significance.
• Alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) and / or total bilirubin (TBIL), or serum creatinine (CR) exceeded the upper limit of normal at screening.
• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at Screening.
• Systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg at screening.
• Vaccinated within 30 days before screening.
• Any drugs that affects the absorption, metabolism or elimination of the drug has been used within 30 days before administration.
• Any drugs or health care products (including Chinese herbal medicine and vitamins) used within 14 days before the first administration of the study.
• Have special requirements for diet and cannot comply with the unified diet.
• Consumption of foods or juices containing alcohol or caffeine, or having strenuous exercise, or other factors affecting the absorption, distribution, metabolism, excretion of drugs with 48 hours before the first dose. Or disagree to stop drinking tea, coffee and / or caffeinated beverages and foods during the trial.

Sponsors & Collaborators

• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: lead

Central Study Contacts

Mengchang Yang Sichuan Provincial People's Hospital, Medical Doctor

CONTACT

86-28-87393401; ymc681@126.com

Study Design

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

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: June 21, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share