Health TrialsbyHealthPanel

A Study of HS-20136-2 in Healthy Participants

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form;

Healthy men and women aged 18-65 years (inclusive);

Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) [BMI = body weight/body height2 (kg/m2)];

Disqualifiers

Pregnant or lactating women;

Participants with a history of cardiovascular, respiratory, hepatic, renal, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities (such as unexplained recurrent hypoglycemia) and other diseases, and not suitable for the study as assessed by the investigator, such as: Childhood asthma (resolved),Depression (non-hospitalised, but potentially medicated in the past), Migraine, etc.

Glycosylated hemoglobin A1c (HbA1c) > 6.5% or fasting blood glucose ≤ 3.9 mmol/L (70 mg/dL) or ≥ 6.1 mmol/L (110 mg/dL) during the screening period;

The alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin (TBIL) > 1.5 × ULN during the screening period (except for cases of known Gilbert's Syndrome);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20136-2 injection

    Drug

    Administrated SC

  • HS-20136-2 injection Placebo

    Drug

    Administrated SC

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: HS-20136-2 injectionExperimental treatment 1 intervention
Group B: HS-20136-2 injection PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse event (AE)

A summary of AEs

Time frame
Time of Inform Consent Form to Day 57
2

Incidence of serious adverse event (SAE)

A summary of SAEs

Time frame
Time of Inform Consent Form to Day 57
3

AE leading to study discontinuation

AE leading to study discontinuation

Time frame
Time of Inform Consent Form to Day 57
4

AE severity and relation with study drug

AE severity and relation with study drug will be reported in the reported adverse events module

Time frame
Time of Inform Consent Form to Day 57

Secondary outcomes

1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)

PK: AUC

Time frame
Baseline to Day 57
2

Pharmacodynamics (PD): glucose change

Changes in fasting blood glucose

Time frame
Baseline to Day 57
3

Pharmacokinetics (PK): Tmax

PK: Tmax

Time frame
Baseline to Day 57
4

Pharmacokinetics (PK): Cmax of HS-20136-2

PK: Cmax of HS-20136-2

Time frame
Baseline to Day 57

Other outcomes

Sponsors and contacts

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

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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