Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- TQH2929 injection
- Conditions
- Psoriasis
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse events (AE) rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This project is divided into a single dose escalation and a multiple dose escalation phase Ia clinical study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQH2929 injection in healthy adults.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged between 18 and 55 years old (inclusive), both male and female;
- •The male subject should weigh at least 50 kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19\~26 kg/m
- •Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, clinical signs, vital signs, full physical examination, 12-lead Electrocardiogram (ECG), Chest radiograph, abdominal ultrasound and clinical laboratory tests.
- •Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content.
- •Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 6 months after the last dose (subjects and their partners).
Exclusion Criteria
- •Pregnant or lactating women;
- •Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and evaluated the investigator to be not suitable for the trial;
- •People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, Chest radiograph and abdominal ultrasound during screening period;
- •Subjects positive for any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP) tests;
- •Subjects positive for tuberculoses spot (T-SPOT) result;
- •Clinically significant infection requiring antibiotic or antiviral therapy prior to screening and the entire study period;
- •Had undergone surgery within 4 weeks prior to screening period or expected to undergo surgery during the study period;
- •Participated in any clinical trial within 3 months prior to the screening period;
- •Received immunoglobulins or blood products within 30 days prior to randomization;
- •Blood donation or significant blood loss of more than 400 mL within 2 months prior to randomization;
Arms & Interventions
TQH2929 Injection (30 mg/kg)
TQH2929 Injection 30 mg/kg is administered as a single dose.
Intervention: TQH2929 injection
Placebo Injection
Placebo injection is administered as a single dose or multiple doses (once every two weeks).
Intervention: Placebo injection
TQH2929 Injection (1 mg/kg)
TQH2929 Injection 1 mg/kg is administered as a single dose.
Intervention: TQH2929 injection
TQH2929 Injection (3 mg/kg)
TQH2929 Injection 3 mg/kg is administered as a single dose.
Intervention: TQH2929 injection
TQH2929 Injection (10 mg/kg)
TQH2929 Injection 10 mg/kg is administered as a single dose.
Intervention: TQH2929 injection
TQH2929 Injection (20 mg/kg)
TQH2929 Injection 20 mg/kg is administered as a single dose.
Intervention: TQH2929 injection
Outcomes
Primary Outcomes
Adverse events (AE) rate
Time Frame: Single dose: Up to Day 113
The occurrence of all adverse events (AE).
Treatment-related adverse events (TRAE) rate
Time Frame: Single dose: Up to Day 113
The occurrence of all treatment-related adverse events (TRAE).
Incidence of clinical laboratory abnormalities
Time Frame: Single administration dose (SAD) group: up to Day 113
Proportion of subjects with clinical laboratory abnormalities
Serious adverse events (SAE) rate
Time Frame: Single dose: Up to Day 113
The occurrence of all adverse events (SAE).
Secondary Outcomes
- Maximum serum concentration (Cmax), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Area under the concentration-time curve from zero to infinity (AUC 0-∞), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Apparent clearance (CL/F), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Time to reach maximum observed serum concentration (Tmax), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Area under the concentration-time curve from 0 to last observation (AUC 0-t), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Apparent volume of distribution (Vd/F), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Half-life (t1/2), SAD(1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.)
- Anti-drug antibodies (ADA)(SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113.)