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Completed

NCT Number: NCT05043792

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects

This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC, Inc.

Baltimore, Maryland, 21201, United States

About this study

This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent must be obtained
  • Age ≥ 18.0 years and ≤ 55.0 years, male or female
  • BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
  • No clinically significant findings in medical examination

Exclusion criteria

  • Known hypersensitivity or allergy to lactose
  • Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
  • Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
  • HbA1c > 5.7 % at Screening
  • Subject with a history of severe visual diseases; or visual changes
  • Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded

Treatment and study plan

TT-00920

Drug

TT-00920 Tablets

TT-00920 Placebo

Drug

TT-00920 Placebo Tablets

Primary outcomes

  1. Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]

    Time frame: 14 days

    • TEAE: Treatment emergent adverse events
    • Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations

Secondary outcomes

  1. Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)

    Time frame: 14 days

  2. Maximum observed plasma concentration at steady state (Cmax, ss)

    Time frame: 14 days

  3. Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)

    Time frame: 14 days

  4. Minimum observed plasma concentration at steady state (Cmin, ss)

    Time frame: 14 days

  5. Trough plasma concentration (Ctrough)

    Time frame: 14 days

  6. Accumulation ratio (Rac)

    Time frame: 14 days

  7. Average concentration (Cav)

    Time frame: 14 days

  8. Volume of distribution at steady state (Vz/F, ss)

    Time frame: 14 days

  9. Clearance at steady state (CL/F, ss)

    Time frame: 14 days

  10. Half-life at steady state (T1/2, ss)

    Time frame: 14 days

Other outcomes

  1. Metabolite characterization in plasma and estimation

    Time frame: 14 days

    observed drug-related material in plasma to determine the presence of any metabolite >10%

  2. Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL)

    Time frame: 14 days

    cGMP: cyclic guanosine monophosphate

  3. Utilization of PGx results

    Time frame: 14 days

    A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response

Sponsors and collaborators

Lead sponsor

TransThera Sciences (Nanjing), Inc.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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