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HealthyPhase 1FTP-198NCT04687813

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

A Phase 1 study of Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteChina
Study dates
23 Dec 2020to 18 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 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;
  • Electrocardiogram morphology consistent with healthy cardiac ventricular conduction and normal rhythm, and with measurement of the QT interval;
  • No family history of short or long QT syndrome;
  • No history of risk factors for torsade de pointes or the diagnosis;
  • Female participants must:
  • Be of nonchildbearing potential ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
  • If of childbearing potential, must have a negative pregnancy test at screening (blood test) and before the first study drug administration (Day -1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug.
  • Male participants, if not surgically sterilized, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug;
  • Have suitable venous access for blood sampling;
  • Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Who cannot join

  • 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;
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  • 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;
  • Use of any live vaccinations within 30 days prior to the first study drug administration except for the influenza vaccine;
  • For women of childbearing potential, a positive serum pregnancy test at screening or a positive urine pregnancy test with confirmatory serum pregnancy test on Day -1;
  • Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study drug administration;
  • Participation in another investigational clinical trial within 60 days prior to the first study drug administration;
  • Any other condition or prior therapy that in the opinion of the PI would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements;
  • Is an employee of an investigator or sponsor or an immediate relative of an investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital SiChuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of FTP 198 in Healthy Volunteers

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
Being tested
Placebo
Keywords
FTP-198, IPF, health, phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

Study groups in NCT04687813
Study groupRoleWhat they receive
Single Ascending Doses 100mgExperimentalDrug: FTP-198, single dose 100mg Drug: Placebo, single dose Placebo matched to FTP-198, tablet
Receives: Drug: Placebo
Single Ascending Doses 300mg(food-impact)ExperimentalDrug: 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)
Receives: Drug: Placebo
Single Ascending Doses 400mgExperimentalDrug: FTP-198, single dose 400mg Drug: Placebo, single dose Placebo matched to FTP-198, tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days after the last doses

Secondary outcomes (4)

  1. The level of changes of pharmacodynamic biomarkers

    The change-from-baseline values of plasma lysophosphatidic acid (LPA) as PD biomarkers

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

  2. Cmax

    peak palsma concentration

    Measured: within 0.5 hours before administration until 48 hours after administration

  3. AUC

    area under the plasma concentration versus time curve

    Measured: within 0.5 hours before administration until 48 hours after administration

  4. t1/2

    half-life

    Measured: within 0.5 hours before administration until 48 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start23 Dec 2020
  3. Primary completion26 Feb 2021
  4. Study completion18 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687813
Sponsor's protocol ID
FTP198-102
Acronym
FTP-198
Status last verified
Jan 2023
First submitted
18 Dec 2020
Last updated
23 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and severity of treatment emergent adverse events (TEAEs) (time frame: 7 days after the last doses). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04687813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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