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

NCT ID: NCT04730050

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2021-12-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug: TT-01025-CL

TT-01025-CL

Group Type: EXPERIMENTAL

TT-01025-CL

Intervention Type: DRUG

Oral tablet

Drug: Placebo

Placebo of TT-01025-CL

Group Type: PLACEBO_COMPARATOR

TT-01025-CL

Intervention Type: DRUG

Oral tablet

Interventions

TT-01025-CL

Oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• A female subject of childbearing potential who is sexually active agrees 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 duration of the study period and for 90 days after last study drug administration. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.

• 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

Exclusion Criteria

• 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)
• Aspartate aminotransferase (AST) > ULN
• Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2

• Women who are pregnant or lactating, or intending to become pregnant before, during or within 90 days after exit from this study.
• Women with baseline FSH ≥40mIU/ml
• Participant who has had a loss of more than 100 mL blood (e.g., a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before Check-in, or plans to donate blood, ova or sperm during the study or within 3 months after the study.
• Participant who has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.
• Participant who has used prescription or over-the-counter (OTC) medication (other than ≤2 g/day paracetamol [acetaminophen] or ≤800 mg/day ibuprofen), vitamins, or herbal remedies, within 7 days or 5 half-lives before study drug administration, whichever is longer.
• Participant who has a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 20 mL of spirits.
• Participant who smokes cigarettes or uses other nicotine-containing products (e.g., vape, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), has done so in the 3 months prior to screening.
• Consumption of caffeine or xanthine-containing food or beverages from at least 72 hours prior to Check-in to the clinical research unit until at least 24 hours after last drug administration
• Participant who has a positive test for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, MDMA, oxycodone, phencyclidine, methamphetamine, tricyclic antidepressants, opiates, methadone, cocaine, cannabinoids, amphetamines, or cotinine) at Screening or Check-in.
• Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.
• Participant who has a positive swab test of COVID-19 from Screening or Check-in testing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

TT01025US01

Identifier Type: -

Identifier Source: org_study_id