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Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1816 in Healthy Subjects | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1816 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1816 in Healthy Subjects

NCT05330208•Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1816 after single and multiple injection with different dose regimens in healthy subjects.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males and infertility females aged between 18 years and 55 years at screening.
•2. Male subjects weight ≥50kg, female subjects weight ≥45kg. Body mass index (BMI) in the range of 19-26kg /m2.
•3. HbA1c\<6.2% at screening.
•4. FPG\>3.9mmol/L (70mg/dL) and \<6.1mmol/L (110mg/dL) at screening
•5. Agree to take effective contraceptive methods.
•6. Able and willing to provide a written informed consent.

Exclusion Criteria

•1. The following clinical laboratory tests or examination abnormalities exist during the screening period:
•1\) Any clinically significant lab tests abnormal with one-time retest. 2) ALT and AST were higher than the upper limit of normal value. 3) Subject who has fatty liver disease diagnosed by ultrasound examination. 4) Subject who has abnormal thyroid function. 5) The 12-lead electrocardiogram (ECG) is abnormal and clinically significant, or shows QTcF\>450 ms in male and 470 ms in female.
•6\) Positive infectious diseases screening tests: HBsAg, HCV-Ab, TP-Ig G, HIV-Ab 2. Having any of the following diseases or history:
•1. Subject with a history of hypertension or with abnormal vital signs and clinical significance.
•2. Subject with a history of life-threatening diseases within the previous 5 years prior to screening.
•3. Subject with severe systemic infectious diseases within 1 month prior to screening.
•4. Subject with medical history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, and previous history of pancreatitis.
•5. Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems.
•3\. Use of any other medicine or other non-drug operations:
•1. Prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration.
+16 more criteria

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Key Dates

Start Date

May 18, 2022

Primary Completion Date

September 5, 2022

Completion Date

September 5, 2022

Last Updated

April 20, 2025

Enrollment

ACTUAL participants

Conditions

Diabetes

Interventions

SHR-1816

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1816 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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