A Study of HS-20094 in Healthy Participants

NCT ID: NCT05116410

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

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This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HS-20094 (Single dose)

Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants.

Group Type EXPERIMENTAL

HS-20094

Intervention Type DRUG

Administrated SC

HS-20094 (Multiple doses)

Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants.

Group Type EXPERIMENTAL

HS-20094

Intervention Type DRUG

Administrated SC

Placebo (Single dose)

Placebo administered SC once in healthy participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administrated SC

Placebo (Multiple doses)

Placebo administered SC once weekly for four weeks in healthy participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administrated SC

Interventions

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HS-20094

Administrated SC

Intervention Type DRUG

Placebo

Administrated SC

Intervention Type DRUG

Other Intervention Names

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HS-20094 injection Placebo injection

Eligibility Criteria

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Inclusion Criteria

1. Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
2. Subjects agree to use an effective method of contraception and avoid sperm or egg donation for the duration of the study and for 6 months following the last dose of investigational product
3. Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise

Exclusion Criteria

1. Pregnant or lactating women
2. Subjects have a medical history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g., repeated hypoglycemia for unknown reasons) and are judged not suitable for this study by the investigator.
3. Subjects with abnormal screening vital signs, physical examination, laboratory examination or 12 lead electrocardiogram results with clinical significance
4. Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptor agonism
5. Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period
6. Have a history of digestive disease (e.g., gastroesophageal reflux disease, gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverse events assessment or any other gastrointestinal disease (e.g., gastric bypass surgery, pyloric stenosis, etc.) that may affect gastric emptying
7. Have a diet, weight loss treatment or significant lifestyle changes prior to 30 days of administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yimin Cui

Role: PRINCIPAL_INVESTIGATOR

Beijing University First Hospital

Locations

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Beijing University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yimin Cui, PhD

Role: CONTACT

66110802 ext. 010

Facility Contacts

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Yimin Cui, PhD

Role: primary

66110802 ext. 010

Other Identifiers

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HS-20094-101

Identifier Type: -

Identifier Source: org_study_id

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