Rheumatoid ArthritisPhase 1NCT06103773
A Study of Single and Multiple Oral Doses of TollB-001
A Phase 1 study testing TollB-001 tablets in people with Rheumatoid Arthritis, run by Toll Biotech Co. Ltd. (Beijing) at 1 site in China.
Trial summary
The primary objective is to evaluate the safety and tolerability of TollB-001 following the administration of single or multiple oral doses in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TollB-001 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2023to 7 Apr 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the age of 18 and 45 (both inclusive) when signing the informed consent form (ICF)
- Able to give a signed written ICF (the consent form must be signed by the subject prior to any study-specific procedures); have a full understanding of the study content, procedures, and possible AEs; and be willing and able to comply with study procedures and follow-up examinations
- Body mass index (BMI, weight [kg]/height2 [m2]) within 19.0-26.0 kg/m2 (both inclusive), with total body weight > 50 kg for male subjects and > 45 kg for female subjects.
- The subjects must be willing to use efficient physical contraception methods with a contraceptive failure rate of<1% with their reproductive age partners within 90 days from signing the ICF to the last administration of the investigational drug (such as condoms , intrauterine devices)
- Male subjects must also be willing to refrain from donating sperm for 90 days from the first administration of the investigational drug to the last administration of the investigational drug
- Results of vital signs, physical examination, laboratory examinations, abdominal and urinary B-ultrasound, 12-lead ECG, and other examination are normal or abnormal but not clinically significant. QT interval corrected for heart rate according to Fridericia's formula (QTcF) must be within the following ranges: QTcF ≤ 450 msec for male subjects, and QTcF ≤ 470 msec for female subjects. Assessment may be repeated if deemed appropriate by the investigator.
- Ability to swallow all IMPs.
Who cannot join
- Subjects were excluded if they meet any of the following exclusion criteria:
- Known or suspected allergy or hypersensitivity to any component of TollB-001, known allergic constitution or allergy to two or more foods or drugs.
- Severe gastrointestinal diseases, such as patients who have undergone major gastrointestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs (except for cholecystectomy, appendectomy, hernia repair), or medical history of ulcer, gastrointestinal bleeding, gastritis, etc.
- History or clinical manifestations of any clinically significant gastrointestinal, gallbladder or biliary tract, renal, urologic, pulmonary, neurological, cardiovascular, endocrinological, hematological, immunologic, dermatologic, metabolic disorder, or psychiatric disease (as determined by the investigator).
- Current or chronic history of liver disease or known hepatic ,or clinically significant of biliary abnormalities , or clinically significant abnormal results of liver function test at screening, including alanine amino transferase (ALT) or/and aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN)or/and total bilirubin > ULN.
- eGFR < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening or on Day-1.
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- Current or history of clinically significant cardiac arrhythmias (symptomatic or asymptomatic).
- Serious infection within 3 months prior to dosing or symptoms of infection within 7 days before dosing, including acute and chronic infections and local infections (bacterial, viral, parasitic, fungal, or other opportunistic pathogens), which is inappropriate to participant as deemed by the investigator.
- Major illness or surgery within 3 months before dosing ,or planned surgery during the study period.
- Intolerance to venipuncture.
- Participation in any clinical study or received any other investigational product or device within 4 weeks prior to the first dose or 5 times the half-life of the specific drug/biologics(whichever is longer), or plan to take an investigational agent during the study.
- Donated blood > 400 mL or significant blood loss (equivalent to 400 mL), or received blood transfusion within 3 months of prior to screening, or have plans to donate blood during the study.
- History of malignancy within 5 years prior to screening (excluding non-melanoma skin cancer that has been resected).
- Positive results of any of the following tests at screening: serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV RNA or HCV antibodies [Ab]), human immunodeficiency virus 1 and 2 (HIV)Ab, or Treponema pallidum (TP) Ab.
- Active tuberculosis (TB) infection indicated by chest radiography orγ-interferon at screening or within 3 months prior to screening. TB test positive, or active or latent TB infection as discretion of the investigator according to clinical practice, or history of TB, or currently receiving treatment for this disease.
- Plans to receive administration of any live vaccine within 4 weeks before dosing or up to 30 days after the last dose of IMP.
- Use of drugs, including prescription, over-the-counter medications herbal products, vitamins, and minerals, within 2 weeks prior to the first dose or within 5 times the elimination half-life of the medication prior to first dosing（whichever is longer）.
- Participated in strenuous exercise from 48 hours prior to Day-1 .
- Unwilling to refrain from any food or beverage containing caffeine or producing xanthine after metabolism (e.g., tea, coffee, chocolate, cola, red cattle) from 24 hours prior to Day -1 and during the study.
- Use of food or beverages likely to influence liver metabolism, within 14 days prior to the first dose of the IMP (e.g., star fruit, pomelos, grapefruit, and Seville oranges). Use of any drugs or nutrients known to modulate cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A and transporter OATP1B1,1B3, OAT3, OCT2 activity (refer to Appendix 3) or any strong or moderate inhibitors or inducers ofCYP1A2, BCRP, OATP1B1, OATP1B3, and OAT3 (refer to Appendix 4) starting from 14 days priorto dose administration on Day 1.
- History of significant alcohol abuse within 6 months prior to screening or use of more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol 40% or 150 mL of wine) within 90 days prior to screening or alcohol breath test >0.0mg/100ml at screening, or unwilling to refrain from consumption of alcohol during the study.
- Use of tobacco or nicotine products or smoking within 90 days (more than 5 cigarettes per day) prior to screening and unwilling to refrain from 24 hours prior to Day -1 and during the study.
- Drug abuse or those who have taken drugs (such as cocaine, phencyclidine, etc.) within one year prior to screening (consultation); Or those who are positive for urine drug abuse screening (methamphetamine, ketamine, MDMA ,tetrahydrocannabinoid acid, morphine) during screening.
- Women who are lactating or positive pregnancy test within at screening or during the study period, or planning to become pregnant during the study period.
- Acute illness occurs or concomitant medication required from screening to dosing.
- Constipated or irregular bowel movements.
- Any other situation that researchers believe may affect the subject's ability to provide informed consent or follow the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses and to Evaluate the Food Effect of TollB-001
The primary objective is to evaluate the safety and tolerability of TollB-001 following the administration of single or multiple oral doses in healthy adult subjects
Read the detailed description
This is a Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of single or multiple dose(s) of TollB-001 administered orally in healthy adult subjects and the food effect on the PK of a single dose of TollB-001 with a randomized, open-label and two-period crossover design.
This study includes three parts. Part A: single ascending dose (SAD) study; Part B: multiple ascending dose (MAD) study; and Part C: FE study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TollB-001 tablets, TollB-001 placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TollB-001 tabletsDrug
Also called TollB-001
TollB-001 treatment
TollB-001 placeboDrug
TollB-001 Placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD-TollB-001 50mg Dosage groups | Experimental | drug：TollB-001 tablets（50mg，single-dose, on the first day） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| SAD-TollB-001 100mg Dosage groups | Experimental | drug：TollB-001 tablets （100mg，single-dose, on the first day） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| SAD-TollB-001 200mg Dosage groups | Experimental | drug：TollB-001 tablets （200mg，single-dose, on the first day） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| SAD-TollB-001 400mg Dosage groups | Experimental | drug：TollB-001 tablets （400mg，single-dose, on the first day） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| SAD-TollB-001 800mg Dosage groups | Experimental | drug：TollB-001 tablets （600mg，single-dose, on the first day） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| MAD- TollB-001 100mg Dosage groups | Experimental | drug：TollB-001 tablets （50mg，Multiple-dose, once per day for 10 days） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| MAD- TollB-001 200mg Dosage groups | Experimental | drug：TollB-001 tablets （100mg，Multiple-dose, once per day for 10 days） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| MAD-TollB-001 400mg Dosage groups | Experimental | drug：TollB-001 tablets （200mg，Multiple-dose, once per day for 10 days） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| MAD-TollB-001 800mg Dosage groups | Experimental | drug：TollB-001 tablets （400mg，Multiple-dose, once per day for 10 days） Receives: Drug: TollB-001 tablets; Drug: TollB-001 placebo |
| FE-Low Dosage groups | Experimental | drug：TollB-001 tablets（Subjects in the fasting-fed sequence group will be administered with TollB-001 under fasting condition in the first period and under fed condition in the second period; subject in the fed-fasting sequence group will be administered with TollB-001 under fed condition in the first period and under fasting condition in the second period. The two periods of cross-administration will have a washout period of 10 days） Receives: Drug: TollB-001 tablets |
| FE-High Dosage groups | Experimental | drug：TollB-001 tablets Subjects in the fasting-fed sequence group will be administered with TollB-001 under fasting condition in the first period and under fed condition in the second period; subject in the fed-fasting sequence group will be administered with TollB-001 under fed condition in thefirst period and under fasting condition in the second period. The two periods of cross-administration will have a washout period of 10 days） Receives: Drug: TollB-001 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell count(physiological parameter) by investigator
Red blood cell count
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
hematocrit(physiological parameter) by investigator
hematocrit
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
hemoglobin(physiological parameter) by investigator
hemoglobin
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
white blood cell count(physiological parameter) by investigator
white blood cell count
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
whiteblood cell differential count(physiological parameter) by investigator
whiteblood cell differential count
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
plateletcount(physiological parameter) by investigator
plateletcount
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
Alanine aminotransferase(physiological parameter) by investigator
Alanine aminotransferase
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
aspartateaminotransferase(physiological parameter) by investigator
aspartateaminotransferase
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
alkaline phosphatase(physiological parameter) by investigator
alkaline phosphatase
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
gamma-glutamyl transpeptidase(physiological parameter) by investigator
gamma-glutamyl transpeptidase
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
total bilirubin(physiological parameter) by investigator
total bilirubin
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
direct bilirubin(physiological parameter) by investigator
direct bilirubin
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
blood ureanitrogen (or blood urea)(physiological parameter) by investigator
blood ureanitrogen (or blood urea)
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
creatinine(physiological parameter) by investigator
creatinine
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
glucose(physiological parameter) by investigator
glucose
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
total protein(physiological parameter) by investigator
total protein
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
creatine kinase(physiological parameter) by investigator
creatine kinase
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
Activated partial thromboplastin time(physiological parameter) by investigator
Activated partial thromboplastin time
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
prothrombin time(physiological parameter) by investigator
prothrombin time
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
internationalnormalized ratio(physiological parameter) by investigator
internationalnormalized ratio
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
fibrinogen(physiological parameter) by investigator
fibrinogen
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine pH(physiological parameter) by investigator
urine pH
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine specific gravity(physiological parameter) by investigator
urine specific gravity
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine glucose(physiological parameter) by investigator
urine glucose
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine protein(physiological parameter) by investigator
urine protein
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urobilinogen(physiological parameter) by investigator
urobilinogen
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine bilirubin(physiological parameter) by investigator
urine bilirubin
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine leukocyte(physiological parameter) by investigator
urine leukocyte
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine ketone body(physiological parameter) by investigator
urine ketone body
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine red blood cells(physiological parameter) by investigator
urine red blood cells
Measured: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
AE/SAE monitoring by ToxicityGrading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials,2007 (70 FR 22664)
AE/SAE monitoring
Measured: First dose up to last follow-up visit（for a maximum of 20 days）
physical examination(physiological parameter) by investigator
The assessments of general appearance, head(including ears, eyes, nose, throat), neck, skin, cardiovascular system, respiratory system,abdominal system, nervous system, musculoskeletal system, and lymphatic system
Measured: First dose up to last follow-up visit（for a maximum of 20 days）;SAD:Screening,Day2,Day5 or ET Visit;MAD:Screening,Day3,Day6,Day9 ,Day11,Day14or ET Visit;FE:Screening,Period 1 Day2,Period 1 Day5;Period 2 Day-1,Period 2 Day2,Period 2 Day5 or ET Visit.
blood pressure(systolic pressure and diastolic pressure)(physiological parameter) by investigator
blood pressure(systolic pressure and diastolic pressure)
Measured: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 to Day14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
pulse(physiological parameter) by investigator
pulse
Measured: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
respiratory rate(physiological parameter) by investigator
respiratory rate
Measured: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
body temperature(physiological parameter) by investigator
body temperature
Measured: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
12-lead ECGs
ECGs done in triplicate; heart rate, PR interval, QT and QTc interval and QRS duration
Measured: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 to Day14 or ET Visit;FE:Screening,Period 1 Day1,Period 1 Day3,Period 1 Day5;Period 2 Day-1,Period 2 Day1,Period 2 Day3,Period 2 Day5 or ET Visit.
B-ultrasound(physiological parameter) by investigator
liver, gallbladder, spleen, pancreas, kidney and bladder
Measured: For a maximum of 20 days;SAD:Screening,Day5 or ET Visit;MAD:Screening,Day14 or ET Visit;FE:Screening,Period 1 Day5;Period 2 Day5 or ET Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start28 Sep 2023
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- wen he, Study director, Chengdu Fifth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103773
- Sponsor's protocol ID
- TLBT-TOLLB-001-I
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses and to Evaluate the Food Effect of TollB-001
- ClinicalTrials.gov ID
- NCT06103773
- Acronym / sponsor ID
- TLBT-TOLLB-001-I
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 27 Oct 2023 (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.
The primary objective is to evaluate the safety and tolerability of TollB-001 following the administration of single or multiple oral doses in healthy adult subjects
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of single or multiple dose(s) of TollB-001 administered orally in healthy adult subjects and the food effect on the PK of a single dose of TollB-001 with a randomized, open-label and two-period crossover design.
This study includes three parts. Part A: single ascending dose (SAD) study; Part B: multiple ascending dose (MAD) study; and Part C: FE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| SAD-TollB-001 50mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets（50mg，single-dose, on the first day） |
| SAD-TollB-001 100mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （100mg，single-dose, on the first day） |
| SAD-TollB-001 200mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （200mg，single-dose, on the first day） |
| SAD-TollB-001 400mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （400mg，single-dose, on the first day） |
| SAD-TollB-001 800mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （600mg，single-dose, on the first day） |
| MAD- TollB-001 100mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （50mg，Multiple-dose, once per day for 10 days） |
| MAD- TollB-001 200mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （100mg，Multiple-dose, once per day for 10 days） |
| MAD-TollB-001 400mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （200mg，Multiple-dose, once per day for 10 days） |
| MAD-TollB-001 800mg Dosage groups | Experimental | Drug: TollB-001 tablets, Drug: TollB-001 placebodrug：TollB-001 tablets （400mg，Multiple-dose, once per day for 10 days） |
| FE-Low Dosage groups | Experimental | Drug: TollB-001 tabletsdrug：TollB-001 tablets（Subjects in the fasting-fed sequence group will be administered with TollB-001 under fasting condition in the first period and under fed condition in the second period; subject in the fed-fasting sequence group will be administered with TollB-001 under fed condition in the first period and under fasting condition in the second period. The two periods of cross-administration will have a washout period of 10 days） |
| FE-High Dosage groups | Experimental | Drug: TollB-001 tabletsdrug：TollB-001 tablets Subjects in the fasting-fed sequence group will be administered with TollB-001 under fasting condition in the first period and under fed condition in the second period; subject in the fed-fasting sequence group will be administered with TollB-001 under fed condition in thefirst period and under fasting condition in the second period. The two periods of cross-administration will have a washout period of 10 days） |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male and female subjects between the age of 18 and 45 (both inclusive) when signing the informed consent form (ICF)
- Able to give a signed written ICF (the consent form must be signed by the subject prior to any study-specific procedures); have a full understanding of the study content, procedures, and possible AEs; and be willing and able to comply with study procedures and follow-up examinations
- Body mass index (BMI, weight [kg]/height2 [m2]) within 19.0-26.0 kg/m2 (both inclusive), with total body weight > 50 kg for male subjects and > 45 kg for female subjects.
- The subjects must be willing to use efficient physical contraception methods with a contraceptive failure rate of<1% with their reproductive age partners within 90 days from signing the ICF to the last administration of the investigational drug (such as condoms , intrauterine devices)
- Male subjects must also be willing to refrain from donating sperm for 90 days from the first administration of the investigational drug to the last administration of the investigational drug
Key exclusion criteria (27 listed)
- Known or suspected allergy or hypersensitivity to any component of TollB-001, known allergic constitution or allergy to two or more foods or drugs.
- Severe gastrointestinal diseases, such as patients who have undergone major gastrointestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs (except for cholecystectomy, appendectomy, hernia repair), or medical history of ulcer, gastrointestinal bleeding, gastritis, etc.
- History or clinical manifestations of any clinically significant gastrointestinal, gallbladder or biliary tract, renal, urologic, pulmonary, neurological, cardiovascular, endocrinological, hematological, immunologic, dermatologic, metabolic disorder, or psychiatric disease (as determined by the investigator).
- Current or chronic history of liver disease or known hepatic ,or clinically significant of biliary abnormalities , or clinically significant abnormal results of liver function test at screening, including alanine amino transferase (ALT) or/and aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN)or/and total bilirubin > ULN.
- eGFR < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening or on Day-1.
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 |
|---|---|---|
| TollB-001 tabletsAlso: TollB-001TollB-001 treatment | Drug | FE-High Dosage groups, FE-Low Dosage groups, MAD- TollB-001 100mg Dosage groups, MAD- TollB-001 200mg Dosage groups, MAD-TollB-001 400mg Dosage groups, MAD-TollB-001 800mg Dosage groups, SAD-TollB-001 100mg Dosage groups, SAD-TollB-001 200mg Dosage groups, SAD-TollB-001 400mg Dosage groups, SAD-TollB-001 50mg Dosage groups, SAD-TollB-001 800mg Dosage groups |
| TollB-001 placeboTollB-001 Placebo | Drug | MAD- TollB-001 100mg Dosage groups, MAD- TollB-001 200mg Dosage groups, MAD-TollB-001 400mg Dosage groups, MAD-TollB-001 800mg Dosage groups, SAD-TollB-001 100mg Dosage groups, SAD-TollB-001 200mg Dosage groups, SAD-TollB-001 400mg Dosage groups, SAD-TollB-001 50mg Dosage groups, SAD-TollB-001 800mg Dosage groups |
Primary outcome
Red blood cell count(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
Red blood cell count
hematocrit(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
hematocrit
hemoglobin(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
hemoglobin
white blood cell count(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
white blood cell count
whiteblood cell differential count(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
whiteblood cell differential count
plateletcount(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
plateletcount
Alanine aminotransferase(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
Alanine aminotransferase
aspartateaminotransferase(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
aspartateaminotransferase
alkaline phosphatase(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
alkaline phosphatase
gamma-glutamyl transpeptidase(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
gamma-glutamyl transpeptidase
total bilirubin(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
total bilirubin
direct bilirubin(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
direct bilirubin
blood ureanitrogen (or blood urea)(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
blood ureanitrogen (or blood urea)
creatinine(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
creatinine
glucose(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
glucose
total protein(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
total protein
creatine kinase(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
creatine kinase
Activated partial thromboplastin time(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
Activated partial thromboplastin time
prothrombin time(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
prothrombin time
internationalnormalized ratio(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
internationalnormalized ratio
fibrinogen(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
fibrinogen
urine pH(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine pH
urine specific gravity(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine specific gravity
urine glucose(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine glucose
urine protein(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine protein
urobilinogen(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urobilinogen
urine bilirubin(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine bilirubin
urine leukocyte(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine leukocyte
urine ketone body(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine ketone body
urine red blood cells(physiological parameter) by investigator
Time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)
urine red blood cells
AE/SAE monitoring by ToxicityGrading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials,2007 (70 FR 22664)
Time frame: First dose up to last follow-up visit（for a maximum of 20 days）
AE/SAE monitoring
physical examination(physiological parameter) by investigator
Time frame: First dose up to last follow-up visit（for a maximum of 20 days）;SAD:Screening,Day2,Day5 or ET Visit;MAD:Screening,Day3,Day6,Day9 ,Day11,Day14or ET Visit;FE:Screening,Period 1 Day2,Period 1 Day5;Period 2 Day-1,Period 2 Day2,Period 2 Day5 or ET Visit.
The assessments of general appearance, head(including ears, eyes, nose, throat), neck, skin, cardiovascular system, respiratory system,abdominal system, nervous system, musculoskeletal system, and lymphatic system
blood pressure(systolic pressure and diastolic pressure)(physiological parameter) by investigator
Time frame: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 to Day14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
blood pressure(systolic pressure and diastolic pressure)
pulse(physiological parameter) by investigator
Time frame: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
pulse
respiratory rate(physiological parameter) by investigator
Time frame: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
respiratory rate
body temperature(physiological parameter) by investigator
Time frame: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 toDay14 or ET Visit;FE:Screening,Period 1 Day1 to Day5;Period 2 Day-1 to Day5 or ET Visit.
body temperature
12-lead ECGs
Time frame: For a maximum of 20 days;SAD:Screening,Day1 to Day5 or ET Visit;MAD:Screening,Day1 to Day14 or ET Visit;FE:Screening,Period 1 Day1,Period 1 Day3,Period 1 Day5;Period 2 Day-1,Period 2 Day1,Period 2 Day3,Period 2 Day5 or ET Visit.
ECGs done in triplicate; heart rate, PR interval, QT and QTc interval and QRS duration
B-ultrasound(physiological parameter) by investigator
Time frame: For a maximum of 20 days;SAD:Screening,Day5 or ET Visit;MAD:Screening,Day14 or ET Visit;FE:Screening,Period 1 Day5;Period 2 Day5 or ET Visit.
liver, gallbladder, spleen, pancreas, kidney and bladder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
wen he study director
Chengdu Fifth People's Hospital
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 TollB-001 tablets in people with Rheumatoid Arthritis, run by Toll Biotech Co. Ltd. (Beijing) at 1 site in China.
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 7 inclusion and 27 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: finished, as of the sponsor's last update on 1 Oct 2026. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Red blood cell count(physiological parameter) by investigator (time frame: Baseline（Screening）up to last follow-up visit(SAD:Screening up to Week 1;MAD:Screening up to Week 2;FE:Screening up to Week 2 plus 10 days)). The study lists 38 primary outcomes in all. 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 1 Oct 2026.