NCT05355129

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2021

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

April 5, 2022

Last Update Submit

February 24, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.

    20 days

  • Percentage of Participants With Clinically relevant changes in vital signs

    Vital signs include temperature, respiratory rate, blood pressure and pulse

    20 days

  • Percentage of Participants With Clinically relevant changes in clinical laboratory tests

    Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.

    20 days

  • Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)

    A standard 12-lead ECG was performed.

    20 days

Secondary Outcomes (9)

  • Derived multiple dose PK parameters

    20 days

  • Derived multiple dose PK parameters

    20 days

  • Derived multiple dose PK parameters

    20 days

  • Derived multiple dose PK parameters

    20 days

  • Derived multiple dose PK parameters

    20 days

  • +4 more secondary outcomes

Other Outcomes (5)

  • TT-00920 metabolites as compared to baseline

    20 days

  • Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL)

    20 days

  • Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification

    20 days

  • +2 more other outcomes

Study Arms (4)

Dose 1

EXPERIMENTAL

low dose

Drug: TT-00920

Dose 2

EXPERIMENTAL

Middle dose

Drug: TT-00920

Dose 3

EXPERIMENTAL

High dose

Drug: TT-00920

Placebo

PLACEBO COMPARATOR
Drug: TT-00920 Placebo

Interventions

TT-00920DRUG

Tablets

Dose 1Dose 2Dose 3
TT-00920 PlaceboDRUG

Tablets

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 male weighs at least 50.0 kg and female weighs at least 45.0 kg

You may not qualify if:

  • 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
  • Subject with a history of severe visual diseases; or visual changes
  • Subject is unable to complete this study for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 320500, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

May 2, 2022

Study Start

November 3, 2021

Primary Completion

June 6, 2022

Study Completion

June 6, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

CN(1)