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

NCT04526496 | Completed Phase 1

• 1 other identifier: FTP198-101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

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 Australian subjects

  7 days after the last doses

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Single Ascending Doses

EXPERIMENTAL

50mg-600mg

Drug: FTP-198, single dose; Drug: Placebo, single dose

Multiple Ascending Doses

EXPERIMENTAL

dose to be determined

Drug: FTP-198, multiple doses; Drug: Placebo, multiple doses

Interventions

FTP-198, single dose DRUG

Single dose of FTP-198, 6 dose levels, oral suspension

Single Ascending Doses

Placebo, single dose DRUG

Placebo matched to FTP-198, oral suspension

Single Ascending Doses

FTP-198, multiple doses DRUG

Multiple doses of FTP-198, 3 dose levels, oral suspension, 7 days

Multiple Ascending Doses

Placebo, multiple doses DRUG

Placebo matched to FTP-198, oral suspension, 7 days

Multiple Ascending Doses

Eligibility Criteria

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

You may qualify if:

• 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;
• PR interval of ≤ 210 msec;

You may not qualify if:

• 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;
• Known hypersensitivity to any of the study drug ingredients;

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, Australia

Location

Study Design

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

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: August 25, 2020
• Study Start: February 24, 2020
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: February 9, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)