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

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.

Inclusion Criteria:

1. Written and signed informed consent.
2. Aged 18-55 years (inclusive), male or female.
3. BMI within 18.0-28.0 kg/m2 (inclusive).
4. Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
5. Have agreed to take effective contraception measures.

Exclusion Criteria:

1. Have any prior clinically serious disease of any system.
2. Known or suspected allergy to the study drug or any of its ingredients.
3. Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
4. History of recurrent or chronic infection within 6 months prior to the first administration.
5. Unable to comply with dietary management during the study period.
6. Pregnant or lactating women.