HealthyPhase 1NCT04730050
A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of TT-01025-CL in Healthy Subjects
A Phase 1 study testing TT-01025-CL in people with Healthy, run by LG Chem at 1 site in United States.
Trial summary
To assess the safety, tolerability and pharmacokinetic characteristics of TT-01025 in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TT-01025-CL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Las Vegas Clinical Research Unit
Las Vegas, Nevada, 89113
About this study
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
To assess the safety, tolerability and pharmacokinetic characteristics of TT-01025 in healthy male subjects
- Conditions
- Healthy
- Being tested
- TT-01025-CL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-01025-CLDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Drug: TT-01025-CL | Experimental | TT-01025-CL Receives: Drug: TT-01025-CL |
| Drug: Placebo | Placebo comparator | Placebo of TT-01025-CL Receives: Drug: TT-01025-CL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 30 days
Secondary outcomes (3)
Cmax
Measured: up to 7 days post-dose
AUC
Measured: up to 7 days post-dose
Terminal half-life
Measured: up to 7 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start17 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730050
- Sponsor's protocol ID
- TT01025US01
- Status last verified
- Nov 2021
- First submitted
- 25 Jan 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04730050
- Acronym / sponsor ID
- TT01025US01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, tolerability and pharmacokinetic characteristics of TT-01025 in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: TT-01025-CL | Experimental | Drug: TT-01025-CLTT-01025-CL |
| Drug: Placebo | Placebo comparator | Drug: TT-01025-CLPlacebo of TT-01025-CL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT-01025-CLOral tablet | Drug | Drug: Placebo, Drug: TT-01025-CL |
Primary outcome
Adverse Events
Time frame: 30 days
3 secondary outcomes
Cmax
Time frame: up to 7 days post-dose
AUC
Time frame: up to 7 days post-dose
Terminal half-life
Time frame: up to 7 days post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TT-01025-CL in people with Healthy, run by LG Chem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.