A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of single subcutaneous injection of SHR-4658 in healthy volunteers and volunteers with elevated blood pressure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able and willing to provide a written informed consent.

Blood pressure as defined in the protocol.

Male or female,aged 18 to 55 years (inclusive).

Meet the weight standard.

Disqualifiers

Known history or current clinically significant disease.

Protocol-defined risk factors for disease.

Participated in clinical trials of other drugs or medical devices.

Pregnant or nursing women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-4658 Injection.

    Drug

    SHR-4658 injection.

  • SHR-4658 Placebo Injection

    Drug

    SHR-4658 placebo injection.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: SHR-4658 GroupExperimental treatment 1 intervention
Group B: SHR-4658 Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
Approximately 16 weeks.

Secondary outcomes

1

Area under the concentration-time curve from time 0 to the last time point (AUC0-last)

Time frame
Approximately 16 weeks.
2

Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

Time frame
Approximately 16 weeks.
3

Maximum observed concentration (Cmax)

Time frame
Approximately 16 weeks.
4

Time to maximum observed concentration (Tmax)

Time frame
Approximately 16 weeks.

Other outcomes

Sponsors and contacts

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

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