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

A Phase I, First-In-Human, Randomized, Double Blind, Placebo Controlled, Single Ascending-Dose and Multi Ascending Dose Study of TT-01025-CL in Healthy Subjects

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: TT-01025-CL

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Drug: TT-01025-CL; TT-01025-CL	Drug: TT-01025-CL; Oral tablet
PLACEBO_COMPARATOR: Drug: Placebo; Placebo of TT-01025-CL	Drug: TT-01025-CL; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax	up to 7 days post-dose
AUC	up to 7 days post-dose
Terminal half-life	up to 7 days post-dose

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TT01025US01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No