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
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
Treatments tested in this trial
- HS-20136-2 injection
- HS-20136-2 injection Placebo
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov