HealthyPhase 1NCT05308940
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects
A Phase 1 study testing TB001 in people with Healthy, run by Shenzhen Turier Biotech Co., Ltd at 1 site in China.
Trial summary
It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy 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?
- TB001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 23 Aug 2022
- 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 and signed informed consent.
- Aged 18-55 years (inclusive), male or female.
- BMI within 18.0-28.0 kg/m2 (inclusive).
- Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
- Have agreed to take effective contraception measures.
Who cannot join
- Have any prior clinically serious disease of any system.
- Known or suspected allergy to the study drug or any of its ingredients.
- Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
- History of recurrent or chronic infection within 6 months prior to the first administration.
- Unable to comply with dietary management during the study period.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects
It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.
- Conditions
- Healthy
- Being tested
- TB001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB001Drug
once-daily subcutaneous injection, on Day 1 in SAD stage
TB001Drug
once-daily subcutaneous injection, on Days 1-7 in MAD stage
PlaceboDrug
once-daily subcutaneous injection, on Day 1 in SAD stage
PlaceboDrug
once-daily subcutaneous injection, on Days 1-7 in MAD stage
| Study group | Role | What they receive |
|---|---|---|
| Single-dose of TB001 | Experimental | In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. Receives: Drug: TB001 |
| Multiple-dose of TB001 | Experimental | In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. Receives: Drug: TB001 |
| Single-dose of placebo | Placebo comparator | In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1. Receives: Drug: Placebo |
| Multiple-dose of placebo | Placebo comparator | In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
Measured: Day 1 and up to Day 28
Secondary outcomes (2)
Pharmacokinetics exposure of TB001 in SAD and MAD stage
Serum concentrations of TB001 at different timepoints before and after TB001 administration.
Measured: Day 1 , Day 7
Observed immunogenicity of TB001 in MAD stage
Number of subjects who develop detectable ADAs and NAb after TB001 administration.
Measured: Day 1, Day 7, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start10 Jan 2022
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Turier Biotech Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308940
- Sponsor's protocol ID
- TB001CT0001
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05308940
- Acronym / sponsor ID
- TB001CT0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shenzhen Turier Biotech Co., LtdUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 4 Apr 2022 (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.
It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-dose of TB001 | Experimental | Drug: TB001In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
| Multiple-dose of TB001 | Experimental | Drug: TB001In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
| Single-dose of placebo | Placebo comparator | Drug: PlaceboIn the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1. |
| Multiple-dose of placebo | Placebo comparator | Drug: PlaceboIn the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written and signed informed consent.
- Aged 18-55 years (inclusive), male or female.
- BMI within 18.0-28.0 kg/m2 (inclusive).
- Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
- Have agreed to take effective contraception measures.
Key exclusion criteria (6 listed)
- Have any prior clinically serious disease of any system.
- Known or suspected allergy to the study drug or any of its ingredients.
- Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
- History of recurrent or chronic infection within 6 months prior to the first administration.
- Unable to comply with dietary management during the study period.
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 |
|---|---|---|
| TB001once-daily subcutaneous injection, on Day 1 in SAD stage | Drug | Single-dose of TB001 |
| TB001once-daily subcutaneous injection, on Days 1-7 in MAD stage | Drug | Multiple-dose of TB001 |
| Placeboonce-daily subcutaneous injection, on Day 1 in SAD stage | Drug | Single-dose of placebo |
| Placeboonce-daily subcutaneous injection, on Days 1-7 in MAD stage | Drug | Multiple-dose of placebo |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Day 1 and up to Day 28
An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
2 secondary outcomes
Pharmacokinetics exposure of TB001 in SAD and MAD stage
Time frame: Day 1 , Day 7
Observed immunogenicity of TB001 in MAD stage
Time frame: Day 1, Day 7, Day 14, Day 28
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 13 Apr 2023.
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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 TB001 in people with Healthy, run by Shenzhen Turier Biotech Co., Ltd 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 5 inclusion and 6 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 13 Apr 2023. 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. 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?
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?
Incidence and severity of adverse events (AEs) (time frame: Day 1 and up to Day 28). 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 13 Apr 2023.