A Phase I Pharmacokinetics Study for KT07 Capsule

NCT05223660 | Completed Phase 1 FDA Drug

• 1 other identifier: KT07-US-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2. The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2. The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.

Conditions

Healthy Adult Subjects; Pharmacokinetics; Safety and Tolerability

Keywords

Phase I; Pharmacokinetics (PK); KT07

Outcome Measures

Primary Outcomes (12)

• Area under the curve (AUC) 0-t

  AUC calculation up to the last measurable concentration

  13 days

• AUC0-∞

  AUC calculation from time 0 to infinity

  13 days

• Maximum (or peak) serum concentration (Cmax)

  Assess the peak concentration of KT07

  13 days

• Time to achieve maximum drug concentration (Tmax)

  Assess when KT07 reach its peak concentration

  13 days

• Trough concentration (Ctrough)

  Assess the lowest concentration of KT07

  13 days

• Time required to reduce the drug concentration to ½ of its initial value (t1/2)

  Assess the half-life of KT07

  13 days

• Volume of plasma cleared of drug per unit time (CL/F)

  Assess the plasma clearance of KT07

  13 days

• Volume of distribution at terminal phase (Vz/F)

  Assess the Volume of distribution of KT07

  13 days

• AUCextrap

  Percentage of AUCinf-pred due to extrapolation from Tlast to infinity

  13 days

• Cmax (Racc_Cmax)

  Maximum concentrations anticipated at plateau

  13 days

• AUC (Racc_AUCss)

  Area under the curve anticipated at plateau

  13 days

• Accumulation factor

  Accumulation factor (R) reflects how much drug is accumulated in the body at steady state after multiple dosing as compared to that after single dosing

  13 days

Secondary Outcomes (3)

• Severity of adverse events

  19 days

• Causality of adverse events

  19 days

• Incidence of adverse events

  19 days

Study Arms (4)

Low dose KT07

EXPERIMENTAL

KT07 single dose (4 capsules) followed by multiple doses for 5 days (tid)

Drug: Low dose KT07

High dose KT07

EXPERIMENTAL

KT07 single dose (6 capsules) followed by multiple doses for 5 days (tid)

Drug: High dose KT07

Low dose placebo

PLACEBO COMPARATOR

Placebo single dose (4 capsules) followed by multiple doses for 5 days (tid)

Drug: Low dose Placebo

High dose placebo

PLACEBO COMPARATOR

Placebo single dose (6 capsules) followed by multiple doses for 5 days (tid)

Drug: High dose Placebo

Interventions

Low dose KT07 DRUG

A single dose of 4 capsules, followed by multiple doses on Days 8-12

Also known as: Lianhua Qinwen

Low dose KT07

High dose KT07 DRUG

A single dose of 6 capsules, followed by multiple doses on Days 8-12

Also known as: Lianhua Qingwen

High dose KT07

Low dose Placebo DRUG

A single dose of 4 capsules, followed by multiple doses on Days 8-12

Also known as: placebo

Low dose placebo

High dose Placebo DRUG

A single dose of 6 capsules, followed by multiple doses on Days 8-12

Also known as: placebo

High dose placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Part 1 of the study is for male only. Part 2 of the study is for both genders.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the screening procedures will be performed.
• to 65 years of age, inclusive, at screening, male or female.
• Body mass index (BMI) between 17.5 and 32.0 kg/m2 at screening.
• Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
• All female subjects of child-bearing potential must have a negative serum pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g, abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 90 days after study drug discontinuation.
• Agrees to the collection of nasopharyngeal (NP) swabs for SARS-CoV-2 testing.

You may not qualify if:

• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
• Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
• Positive SARS-CoV-2 testing by standard RT-PCR assay.
• Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• Positive urine test for ethanol/drug/cotinine at Screening or Day -1.
• History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake \> 21 units/week or are unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until completion of the study. Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
• History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator or are unwilling to abstain from illicit drug use consumption during the entire study. Positive drug test, including marijuana.
• Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive consumption is defined as \>6 servings per day (1 serving contains approximately 120 mg caffeine).
• Donation of blood (\> 500 mL) or blood products within 2 months prior to Day -1.
• Use of over-the-counter (OTC) vitamins and medications, prescription medications, an investigational drug or herbal remedies from 14 days prior to the first dose.
• Subject has a history of hypersensitivity to the investigational product (IP) or any of the ingredient or excipient of IP.
• Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to admission.
• Subject has consumed grapefruit or grapefruit juice within the 14 days prior to admission.

Sponsors & Collaborators

• Yiling Pharmaceutical Inc.: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Nan Zhang, PhD

  Yiling Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1 of the study is open-label. Part 2 of the study is double-blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: February 4, 2022
• Study Start: January 7, 2022
• Primary Completion: July 20, 2022
• Study Completion: September 6, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)