Safety, Tolerability and Pharmacokinetics of FTP-198 Tablet in Healthy Chinese Volunteers

NCT04687813 | Completed Phase 1

• 1 other identifier: FTP198-102
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, single-dose escalation clinical trial for FTP-198 conducted in chinese healthy volunteers. The safety, tolerability, food-impact and pharmacokinetics of FTP-198 tablet in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

Conditions

Healthy

Keywords

FTP-198; IPF; health; phase I

Outcome Measures

Primary Outcomes (1)

• The number and severity of treatment emergent adverse events (TEAEs)

  To assess the safety and tolerability of single and multiple ascending oral doses of FTP-198 in healthy Chinese subjects

  7 days after the last doses

Secondary Outcomes (4)

• The level of changes of pharmacodynamic biomarkers

  within 0.5 hours before administration until 24 hours (single dose) or 48 hours (multiple doses) after administration

• Cmax

  within 0.5 hours before administration until 48 hours after administration

• AUC

  within 0.5 hours before administration until 48 hours after administration

• t1/2

  within 0.5 hours before administration until 48 hours after administration

Study Arms (3)

Single Ascending Doses 100mg

EXPERIMENTAL

Drug: FTP-198, single dose 100mg Drug: Placebo, single dose Placebo matched to FTP-198, tablet

Drug: Placebo

Single Ascending Doses 300mg(food-impact)

EXPERIMENTAL

Drug: FTP-198, single dose 300mg Drug: Placebo, single dose Placebo matched to FTP-198, tablet 2-X: fasting (Period 1) ; 2-Y:Postprandial (Period 1) 2-X:Postprandial (Period 2); 2-Y:fasting (Period 2)

Drug: Placebo

Single Ascending Doses 400mg

EXPERIMENTAL

Drug: FTP-198, single dose 400mg Drug: Placebo, single dose Placebo matched to FTP-198, tablet

Drug: Placebo

Interventions

Placebo DRUG

Placebo is a tablet with the same appearance as FTP-198

Single Ascending Doses 100mg; Single Ascending Doses 300mg(food-impact); Single Ascending Doses 400mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers will be included in Part A or Part B of the study if they satisfy all the following criteria:
• Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
• Adult males and females, 18 to 55 years of age (inclusive) at screening;
• Body mass index ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight ≥ 50 kg at screening;
• Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 1 month prior to first study drug administration;
• Medically healthy without clinically significant abnormalities at screening and predose on Day 1, including:
• Physical examination without any clinically relevant findings;
• Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position;
• Heart rate in the range of 50 to 100 bpm after 5 minutes rest in supine position;
• Body temperature, between 35.0°C and 37.5°C;
• No clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the investigator;
• Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at screening and predose on Day 1) consistent with normal cardiac conduction and function, including:
• Normal sinus rhythm with HR between 50 and 100 bpm, inclusive;
• QT interval corrected using the Fridericia method (QTcF) between 350 to 450 msec for male subjects and 350 to 470 msec for female subjects, inclusive;
• QRS duration of \< 120 msec;

You may not qualify if:

• Healthy volunteers will be excluded from Part A or Part B of the study if there is evidence of any of the following at screening, Day -1 or predose on Day 1:
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
• Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
• Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma);
• Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia;
• Use of or plans to use systemic immunosuppressive (eg, corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (eg, interferon) during the study or within 4 months prior to the first study drug administration;
• Liver function test results (ie, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and gammaglutamyl transferase \[GGT\]) and total bilirubin must not be elevated more than 1.2-fold above the upper limit of normal (ULN);
• Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies (Abs);
• History of active, latent or inadequately treated tuberculosis infection;
• Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs;
• Estimated creatinine clearance (CrCl) \< 40 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN;
• History of substance abuse or alcohol abuse within 12 months prior to first study drug administration;
• Positive drug or alcohol test results;
• Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol;
• Demonstrated clinically significant (required intervention, eg, emergency room visit, epinephrine administration) allergic reactions (eg, food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the investigator, would interfere with the volunteer's ability to participate in the trial;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

West China Hospital SiChuan University

Chengdu, Sichuan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 29, 2020
• Study Start: December 23, 2020
• Primary Completion: February 26, 2021
• Study Completion: March 18, 2021
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)