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

TransThera Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TT-00920; Drug: TT-00920 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05043792

TT00920US03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

Dose 1 (Low dose)

Active Comparator group

Description:

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

Treatment:

Drug: TT-00920

Dose 2 (High dose)

Active Comparator group

Description:

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

Treatment:

Drug: TT-00920

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: TT-00920 Placebo