A Clinical Study of TQH2929 in Healthy Adult Subjects

NCT06156280 | Completed Phase 1

• 1 other identifier: TQH2929-I-01 (Ia)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

• Adverse events (AE) rate

  The occurrence of all adverse events (AE).

  Single dose: Up to Day 113

• Serious adverse events (SAE) rate

  The occurrence of all adverse events (SAE).

  Single dose: Up to Day 113

• Treatment-related adverse events (TRAE) rate

  The occurrence of all treatment-related adverse events (TRAE).

  Single dose: Up to Day 113

• Incidence of clinical laboratory abnormalities

  Proportion of subjects with clinical laboratory abnormalities

  Single administration dose (SAD) group: up to Day 113

Secondary Outcomes (8)

• 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.

• 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.

• 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.

Study Arms (6)

TQH2929 Injection (1 mg/kg)

EXPERIMENTAL

TQH2929 Injection 1 mg/kg is administered as a single dose.

Drug: TQH2929 injection

TQH2929 Injection (3 mg/kg)

EXPERIMENTAL

TQH2929 Injection 3 mg/kg is administered as a single dose.

Drug: TQH2929 injection

TQH2929 Injection (10 mg/kg)

EXPERIMENTAL

TQH2929 Injection 10 mg/kg is administered as a single dose.

Drug: TQH2929 injection

TQH2929 Injection (20 mg/kg)

EXPERIMENTAL

TQH2929 Injection 20 mg/kg is administered as a single dose.

Drug: TQH2929 injection

TQH2929 Injection (30 mg/kg)

EXPERIMENTAL

TQH2929 Injection 30 mg/kg is administered as a single dose.

Drug: TQH2929 injection

Placebo Injection

PLACEBO COMPARATOR

Placebo injection is administered as a single dose or multiple doses (once every two weeks).

Drug: Placebo injection

Interventions

TQH2929 injection DRUG

TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.

TQH2929 Injection (1 mg/kg); TQH2929 Injection (10 mg/kg); TQH2929 Injection (20 mg/kg); TQH2929 Injection (3 mg/kg); TQH2929 Injection (30 mg/kg)

Placebo injection DRUG

Placebo comparator

Placebo Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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/m2.
• 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).

You may not qualify if:

• 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;
• People who have potential difficulty in blood collection, or have a history of needles or blood sickness；
• Any clear history of drug or food allergies, particularly those with allergies to similar components to the investigational drugs in this trial;
• People who have received or are planning to receive inactivated or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);
• Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products within 6 months prior to randomization, or those who cannot stop using any tobacco-based products during the trial;
• People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week within 3 months prior to screening, or those who cannot refrain from alcohol during the trial, or those who tested positive for alcohol breath;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100871, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: November 21, 2023
• Primary Completion: August 2, 2024
• Study Completion: March 21, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CN (1)