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

NCT05043792 | Completed Phase 1 FDA Drug

• 1 other identifier: TT00920US03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

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]

  * 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

  14 days

Secondary Outcomes (10)

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

  14 days

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

  14 days

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

  14 days

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

  14 days

• Trough plasma concentration (Ctrough)

  14 days

Other Outcomes (3)

• Metabolite characterization in plasma and estimation

  14 days

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

  14 days

• Utilization of PGx results

  14 days

Study Arms (3)

Dose 1 (Low dose)

ACTIVE COMPARATOR

TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Drug: TT-00920

Dose 2 (High dose)

ACTIVE COMPARATOR

TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Drug: TT-00920

Placebo

PLACEBO COMPARATOR

TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Drug: TT-00920 Placebo

Interventions

TT-00920 DRUG

TT-00920 Tablets

Dose 1 (Low dose); Dose 2 (High dose)

TT-00920 Placebo DRUG

TT-00920 Placebo Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 weighs at least 50.0 kg
• No clinically significant findings in medical examination

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
• 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

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (1)

Pharmaron CPC, Inc.

Baltimore, Maryland, 21201, United States

Location

Study Design

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

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 14, 2021
• Study Start: August 19, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)