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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730050
Recruitment Status : Active, not recruiting
First Posted : January 29, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
LG Chem

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

Condition or disease Intervention/treatment Phase
Healthy Drug: TT-01025-CL Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 17, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Cmax [ Time Frame: up to 7 days post-dose ]
  2. AUC [ Time Frame: up to 7 days post-dose ]
  3. Terminal half-life [ Time Frame: up to 7 days post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730050


Locations
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United States, Nevada
Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States, 89113
Sponsors and Collaborators
LG Chem
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04730050    
Other Study ID Numbers: TT01025US01
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No