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Study of IBI3016 in People With Mild or Moderate Hypertension Patients

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent.

Disqualifiers

Known history of secondary hypertension.

Orthostatic hypotension.

Laboratory parameter assessments outside of range at screening：

Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2× Upper Limit of Normal (ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI3016

    Drug

    Solution of Injection

  • Placebo

    Other intervention

    0.9% sodium chloride saline solution

Treatment groups

30 Participants
are divided into 5 treatment groups
Group A: IBI3016 dose 4Experimental treatment 1 intervention
Group B: IBI3016 dose 3Experimental treatment 1 intervention
Group C: IBI3016 dose 2Experimental treatment 1 intervention
Group D: IBI3016 dose 1Experimental treatment 1 intervention
Group E: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety indicators-Number of Participants with Adverse Events (AEs)

up to approximately 12 months

Time frame
from baseline to week 12

Secondary outcomes

1

Plasma pharmacokinetic parameters-peak concentration（Cmax）

Time frame
from baseline to week 12
2

Urinary pharmacokinetic parameters-drug amount excreted(Ae)

Time frame
from baseline to week 12
3

Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by 24-hour ambulatory blood pressure monitoring

Time frame
from baseline to week 12
4

Plasma pharmacokinetic parameters-Time to peak concentration（Tmax）

Time frame
from baseline to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: