Phase I Clinical Trial of TQC2731 Injection (NCT04923607) | Clinical Trial Compass
UnknownPhase 1
Phase I Clinical Trial of TQC2731 Injection
China96 participantsStarted 2021-06-25
Plain-language summary
This is the first-in-human phase 1 trial of TQC2731 injection in healthy subjects and in patients with severe asthma to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy subjects:Sign the informed consent form before the trial, fully understand the trial purpose, process and possible adverse reactions.
* Healthy subjects:Aged between 18 and 60 years old, both men and women;
* Healthy subjects:Female ≥45kg, male ≥50kg, body mass index (BMI) is 18-28 kg/m\^2 (including the critical value), BMI=weight (kg)/height\^2 (m\^2);
* Asthma subjects:Aged between 18 and 70 years old, both men and women;
* Asthma subjects:Female ≥45kg, male ≥50kg;
* Asthma subjects:according to the GINA guidelines (GINA 2020), subjects who received middle, or high-dose ICS in asthma control drugs prescribed by the doctor at least 6 months prior to Visit 1;
Exclusion Criteria:
* Healthy subjects: Pregnant and lactating women;
* Healthy subjects:preexisting or existing heart, endocrine, metabolism, kidney, liver, gastrointestinal, skin, infection, blood, nerve, mental diseases or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial;
* Healthy subjects:Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, and chest radiograph during the screening period are abnormal and have clinical significance;
* Healthy subjects:Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) and Treponema pallidum antibody (Anti-TP), any of the above positive subject…
What they're measuring
1
(healthy subject)Number of participants with abnormal clinical symptoms
Timeframe: appropriatly up to Day 253
2
(healthy subject)Number of participants with abnormal physical examination
Timeframe: appropriatly up to Day 253
3
(healthy subject)Number of participants with abnormal vital signs
Timeframe: appropriatly up to Day 253
4
(asthma subject)Number of participants with abnormal laboratory examinations
Timeframe: appropriatly up to Day 253
Trial details
NCT IDNCT04923607
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.