- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05045534
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TB-840 in Healthy Subjects
July 26, 2023 updated by: Therasid Bioscience
A Dose Block-randomized, Double-blind, Placebo Controlled, Single-/Multiple-dosing, Dose-escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of TB-840 (NASH Treatment Candidate) After Oral Administration in Healthy Subjects
TB-840(Agonist of RORα) is a candidate for NASH treatment that activates RORα(Retinoid-related orphan receptor) and its target validation for RORα and potential as a NASH treatment.
This study is a dose block-randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study.
For each dose group, 6 subjects will be randomly assigned to the test group (TB-840) and 2 subjects will be randomly assigned to the control group (placebo).
Adverse event (AE) monitoring, physical examination, vital signs, ECG, clinical laboratory test will be done for safety and tolerability assessment, and blood and urine samples will be collected for Pharmacokinetic (PK) assessment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YoungHee Shin
- Phone Number: +82317070737
- Email: yhshin@therasidbio.com
Study Contact Backup
- Name: Yunji Lee
- Phone Number: +82317070737
- Email: yjlee@therasidbio.com
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13488
- Therasid Bioscience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy adults aged ≥ 19 and ≤ 45 years at the time of screening visit
- BMI of ≥ 18.0 and ≤ 27.0 kg/m2 at the time of screening visit
- Clinically confirmed as healthy based on the medical history, physical examination, vital signs, electrocardiography (ECG), and proper laboratory tests (Subjects with values out of the normal range may participate in the study if they are deemed clinically insignificant by the investigator.)
- Agree to use medically acceptable methods of contraception by participant, his/her spouse, or partner and not to donate sperm or oocyte from the date of the first dose of the investigational product (IP) until 90 days after the last dose of the IP
- Examples of medically acceptable methods of contraception
- Females (females who use oral hormonal contraceptives and subcutaneous hormonal contraceptive implants may be excluded from the study)
- Use of an intrauterine device with a proven pregnancy failure rate
- Use of barrier method with spermicide
- Surgical sterilization (salpingectomy/tubal ligation, hysterectomy, etc.)
- Males
- Use of barrier method with spermicide
- Surgical sterilization (vasectomy, vasoligation, etc.)
- Voluntarily decided to participate in the study and provided written consent to comply with the protocol
Exclusion Criteria:
- Current or history of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, or cardiovascular disease
- History of gastrointestinal diseases (e.g., Crohn's disease, ulcer, etc.) or surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of the investigational products
- History of clinically significant hypersensitivity to drugs containing RORα agonist or other ingredients of the same class, or other drugs (aspirin and non-steroidal anti-inflammatory drugs, antibiotics, etc.)
- History of drug abuse or positive result from urine drug screening of drugs with concerns of drug abuse
- Subjects with any of the following results at the time of screening visit:
- Systolic blood pressure: < 90 mmHg or > 140 mmHg
- Diastolic blood pressure: < 50 mmHg or > 90 mmHg
- Heart rate: < 50 bpm or > 100 bpm
- AST: > x 1.5 ULN
- ALT: > x 1.5 ULN
- ALP: > x 1.5 ULN
- T.bil: > x 1.5 ULN
- γ-GT: > x 1.5 ULN
- Serum creatinine: > x 1.5 ULN
- Participated in another bioequivalence study or clinical study and have been exposed to an investigational product within 6 months prior to the date of the first dose of this study
- Donated whole blood within 2 months or blood components within 1 month, or received blood transfusion within 1 month prior to the date of the first dose of this study
- Use of drug-metabolizing enzyme inducer or inhibitor such as barbiturates within 1 month prior to the date of the first dose of this study
- Consumption of caffeine- or grapefruit-containing foods or beverages within 3 days prior to the date of the first dose of this study
- Use of any prescription drugs or herbal medicines within 1 month, or any over-the-counter (OTC) drugs within 1 week prior to the date of the first dose of this study (Subjects may participate in the study if such use is judged not to significantly affect the assessment of safety and pharmacokinetics by the investigator.)
- Excessive intake of caffeine, excessive intake of alcohol, or heavy smoking (caffeine > 5 units/day, alcohol > 21 units/week [1 unit = 10 mL of pure alcohol], smoking > 10 cigarettes/day)
- Unable to consume meals provided by the study site
- Prior participation in this study
- Positive result in serology tests (hepatitis B tests, human immunodeficiency virus [HIV] tests, hepatitis C tests, or syphilis tests [RPR])
- Determined inappropriate for the study by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 Single Dose SD1 (first dose)
Group SD1 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 2 Single Dose SD2 (second dose)
Group SD2 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 3 Single Dose SD3 (third dose)
Group SD3 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 4 Single Dose SD4 (fourth dose)
Group SD4 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 5 Single Dose SD5 (fifth dose)
Group SD5 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 6 Single Dose SD6 (sixth dose)
Group SD6 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 7 Single Dose SD7 (seventh dose)
Group SD7 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 8 Single Dose SD8 (eighth dose)
Group SD8 a first single dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 9 : Mutiple Dose MD1
Group MD1 a first multiple dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 10 : Mutiple Dose MD2
Group MD2 a first multiple dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
Experimental: Cohort 11 : Mutiple Dose MD3
Group MD3 a first multiple dose of TB-840(n=6) or placebo(n=2)
|
Single dose or Multiple Dose of TB-840 treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Time Frame: Up to 10 days from single ascending dose
|
Incidences of treatment-emergent adverse events
|
Up to 10 days from single ascending dose
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Time Frame: Up to 14 days from multiple ascending dose
|
Incidences of treatment-emergent adverse events
|
Up to 14 days from multiple ascending dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration of drug in plasma[Cmax]
Time Frame: Up to 4 days from single ascending dose
|
Pharmacokinetic Profile of TB-840
|
Up to 4 days from single ascending dose
|
Maximum concentration of drug in plasma[Cmax]
Time Frame: Up to 8 days from multiple ascending dose
|
Pharmacokinetic Profile of TB-840
|
Up to 8 days from multiple ascending dose
|
Area under the plasma drug concentration-time curve[AUC]
Time Frame: Up to 4 days from single ascending dose
|
Pharmacokinetic Profile of TB-840
|
Up to 4 days from single ascending dose
|
Area under the plasma drug concentration-time curve[AUC]
Time Frame: Up to 8 days from multiple ascending dose
|
Pharmacokinetic Profile of TB-840
|
Up to 8 days from multiple ascending dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2021
Primary Completion (Actual)
August 29, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
September 14, 2021
First Posted (Actual)
September 16, 2021
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- TB-840-PRT-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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