Study of SYH2062 Injection in Healthy Chinese Volunteers
ConditionHealthy Chinese Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
About this trial
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
Age of 18 - 55 years (inclusive).
BMI: 19.0-26.0 kg/m² (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.
Has Systolic blood pressure (SBP) ≥100 mmHg and <140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and <90 mmHg at screening;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
SYH2062 injection
DrugSYH2062 for sc injection
SYH2062-Matching placebo
DrugNormal saline matching volume of SYH2062 doses will be administered
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: SYH2062 injectionExperimental treatment 1 intervention
Group B: SYH2062-Matching placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
Time frame
up to approximately 12 monthsSecondary outcomes
1
Change from Baseline in Blood Angiotensinogen (AGT) Level
Time frame
up to approximately 12 months2
Change from Baseline in in plasma renin concentration
Time frame
up to approximately 12 months3
Change from Baseline in in plasma renin activity
Time frame
up to approximately 12 months4
Change from Baseline in in angiotensin I
Time frame
up to approximately 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov