A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: TB001
* Drug: TB001
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-dose of TB001<br>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. | Drug: TB001<br>* once-daily subcutaneous injection, on Day 1 in SAD stage<br>|
| Experimental: Multiple-dose of TB001<br>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. | Drug: TB001<br>* once-daily subcutaneous injection, on Days 1-7 in MAD stage<br>|
| Placebo Comparator: Single-dose of placebo<br>In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1. | Drug: Placebo<br>* once-daily subcutaneous injection, on Day 1 in SAD stage<br>|
| Placebo Comparator: Multiple-dose of placebo<br>In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days. | Drug: Placebo<br>* once-daily subcutaneous injection, on Days 1-7 in MAD stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics exposure of TB001 in SAD and MAD stage | Serum concentrations of TB001 at different timepoints before and after TB001 administration. | Day 1 , Day 7 | 
| Observed immunogenicity of TB001 in MAD stage | Number of subjects who develop detectable ADAs and NAb after TB001 administration. | Day 1, Day 7, Day 14, Day 28 |