A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

Obesity Clinical Trial

Official title:

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05943886
• Other study ID #: HEC88473-DM-101
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2021
• Est. completion date: February 17, 2023

Study information

• Verified date: July 2023
• Source: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).

Description:

This study is divided into two parts, Part A is an escalating single-dose study in healthy subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Part A

1. Males or females, between 18 and 45 years of age, inclusive, at screening.

2. Body weight = 50 kg for males and body weight = 45 kg for females. 18=body mass index (BMI)<28 kg/m2 for nonobese subjects and 28=BMI=45 kg/m2 for obese subjects.

Part B

1. Males or females, between 18 and 65 years of age, inclusive, at screening.

2. 24 kg/m2=BMI=35 kg/m2.

3. Subjects diagnosed with T2DM, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for = 3 months before screening.

4. 7.0%= HbA1c =10.5% at screening.

Exclusion Criteria:

Part A

1. Smoked more than 5 cigarettes per day within 3 months before the study.

2. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.

3. Positive alcohol breath test result or positive urine drug screen.

4. Blood donation (> 300 mL) or massive blood loss (> 400 mL) within 3 months before screening.

Part B

1. Have type 1 diabetes mellitus.

2. Have had =1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).

3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >5 times the upper limit of the reference range at screening.

4. Have serum calcitonin =20 ng/L at screening.

5. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce MTC.

6. Fasted triglycerides > 5.7 mmol/L at screening. If the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy Subjects
• Obesity
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
• Placebo
Placebo will be administered by subcutaneous injection in the abdomen.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473	Adverse Events (AEs)	Baseline to day 15
Primary	Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473	Adverse Events (AEs)	Baseline to day 43
Primary	Cmax	Maximum observed serum concentration of HEC88473	Predose and postdose 4?8?10?12?14?24?48?72?96?168?216?336 hours
Primary	AUC	Area under the serum concentration-time curve (AUC)	Predose and postdose 4?8?10?12?14?24?48?72?96?168?216?336 hours
Secondary	OGTT	Oral glucose tolerance test	Day-1, Day3 and Day 7
Secondary	Change from baseline of Adiponectin at day 38	Adiponectin	Baseline to day 38
Secondary	Fasting lipid concentration	Fasting lipid concentration	Baseline to day 43
Secondary	Change from baseline of HbA1c at day 38	HbA1c	Baseline to day 38
Secondary	Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing	anti drug antibodies (ADA)	Baseline to day 43