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A Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.
Details
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 48 |
| Start date | 2022-06 |
| Completion | 2023-08 |
Conditions
- Atopic Dermatitis
Interventions
- TQH2722 injection
- Placebo to match TQH2722
Primary outcomes
- Adverse events (AE) — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Incidence and severity of adverse events (AE) . - Serious adverse events (SAE) — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Incidence and severity of Serious adverse events (SAE). - Blood biochemistry — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of blood biochemistry. - Coagulation function — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of coagulation function. - Blood routine — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of blood routine. - Urinalysis — From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Abnormal indicators of urinalysis.
Countries
China