Phase I, First-In-Human Study of TT-00920 in Healthy Subjects

TransThera Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebos; Drug: TT-00920

Study type: Interventional

Funder types: Industry

Identifiers

NCT04364789

TT00920US01

Details and patient eligibility

About

This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.

Full description

There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.

In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8 subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose periods (Fasted/ Fed) in an open-label, crossover design.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Age ≥ 18 years and ≤ 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone [FSH] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.
• No clinically significant findings in medical examination

Exclusion criteria

• Any history of clinically serious disease.
• Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
• Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test
• Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests [color discrimination (Ishihara test) and visual acuity (Snellen chart).
• Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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42 participants in 7 patient groups, including a placebo group

Pilot dose Cohort

Active Comparator group

Description:

A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.

Treatment:

Drug: TT-00920

SAD Dose 1

Active Comparator group

Treatment:

Drug: TT-00920

SAD Dose 2

Active Comparator group

Treatment:

Drug: TT-00920

SAD Dose 3

Active Comparator group

Treatment:

Drug: TT-00920

SAD Dose 4

Active Comparator group

Treatment:

Drug: TT-00920

Food Effect Cohort

Active Comparator group

Treatment:

Drug: TT-00920

Placebo

Placebo Comparator group

Treatment:

Drug: Placebos