A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of TT-01025-CL in Healthy Subjects

NCT04730050 | Unknown Phase 1 FDA Drug

• 1 other identifier: TT01025US01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety, tolerability and pharmacokinetic characteristics of TT-01025 in healthy male subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  30 days

Secondary Outcomes (3)

• Cmax

  up to 7 days post-dose

• AUC

  up to 7 days post-dose

• Terminal half-life

  up to 7 days post-dose

Study Arms (2)

Drug: TT-01025-CL

EXPERIMENTAL

TT-01025-CL

Drug: TT-01025-CL

Drug: Placebo

PLACEBO COMPARATOR

Placebo of TT-01025-CL

Drug: TT-01025-CL

Interventions

TT-01025-CL DRUG

Oral tablet

Drug: Placebo; Drug: TT-01025-CL

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 before any assessment is performed.
• Age ≥ 18 years and ≤ 55 years, male or female.
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.
• No clinically significant findings in medical examination, including physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory tests.
• Male participant and his female spouse/partner who is of childbearing potential agree to use highly effective contraception\* consisting of two forms of birth control (at least one of which must be a barrier method) from signing of informed consent throughout the study period and for 90 days after final study drug administration.
• Highly effective contraception is defined as:
• Established use of oral, injected, or implanted hormonal methods of contraception
• Placement of an intrauterine device or intrauterine system
• Barrier methods of contraception: condom with spermicidal foam, gel, film, cream, suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository
• Able to understand and sign informed consent and to comply with the protocol

You may not qualify if:

• Any history of clinically serious disease.
• Any active or unstable clinically significant medical condition as judged by the investigator.
• Subject has abnormal Screening findings or Day -2 laboratory value that suggest a clinically significant underlying disease.
• Hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes.
• Received any investigational drug within 30 days or 5x T1/2 whichever is longer before the Screening.
• Participants who have undergone major surgery ≤ 2 months prior to start study drug.
• Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test, including but not limited to any of the following at Screening and
• Check-in, repeat testing is allowed for verification, at the discretion of the Investigator:
• Heart rate \< 45 beats per minute (bpm) or \> 90 bpm (taken during blood pressure measurement).
• Systolic blood pressure (SBP) \< 90 mmHg or \> 140 mmHg; diastolic blood pressure (DBP) \< 50 mmHg or \> 90 mmHg.
• Average of the 3 QT intervals corrected using Fridericia's formula (QTcF) \> 450 milliseconds.
• Second degree or higher Atrioventricular block on ECG
• Estimated glomerular filtration rate (eGFR) \< 90 ml/min/1.73m2
• Impaired renal function or abnormal liver enzymes at baseline, including but not limited to:
• Alanine aminotransferase (ALT) \> upper limit of normal (ULN)

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: February 17, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)