Health TrialsbyHealthPanel

A Study of SYH2092 Injection in Healthy Participants

ConditionOverweight or Obesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

To evaluate the safety and tolerability of SYH2092 Injection in healthy participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Fully understand the content, process and possible adverse drug reactions (ADRs) of the study before the study, and voluntarily sign the ICF;

At Screening, aged 18 to 60 years (inclusive, based on the date of signing the ICF), including both males and females;

At Screening, body weight ≥ 50 kg with a body mass index (BMI) of 18 to 35 kg/m²

Body weight change ≤ 5% within 3 months prior to Screening (including the Screening Period) (based on participant self-report);

Disqualifiers

Known or suspected allergy to amylin receptor agonists or any component of the investigational product; or those with an allergic constitution (allergy to multiple drugs and foods);

Clinically significant abnormal results in vital signs, physical examination, laboratory tests, or ECG, as judged by the Investigator, that render the participant unsuitable for the study. The following conditions do not lead to exclusion: (1) TG ≤ 3.42 mmol/L, TC ≤ 7.5 mmol/L, HDL-C abnormal; (2) alanine aminotransferase (ALT) < 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5 × ULN, or total bilirubin <1.5 × ULN;

HbA1c ≥ 6.5% during Screening Period, or fasting glucose < 3.9 mmol/L or ≥ 7 mmol/L;

Prolonged QTcF interval during Screening Period (≥ 450 ms for males; ≥ 460 ms for females; see Section 13.5 for calculation formula), history of risk factors for Torsades de Pointes (e.g., cardiac failure/cardiomyopathy, or family history of long QT syndrome);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYH2092 Injection

    Drug

    Conduct in accordance with the study protocol.

  • Placebo

    Drug

    Conduct in accordance with the study protocol.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: SYH2092 InjectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as accessed by CTCAE v6.0

Time frame
Screening period up to day 71

Secondary outcomes

1

Maximum plasma concentration (Cmax)

Time frame
predose on day 1 to day 71
2

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

Time frame
predose on day 1 to day 71
3

Area under the concentration time curve from time 0 to infinity (AUCinf)

Time frame
predose on day 1 to day 71
4

Percent of AUC extrapolated to infinity (AUC_Extrap)

Time frame
predose on day 1 to day 71

Other outcomes

Sponsors and contacts

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

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

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