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

NCT05330208 | Terminated Phase 1

• 1 other identifier: SHR-1816-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• Number of adverse Events

  Day-2 to Day29/Day50

• Incidence of hypoglycemic events

  Day1 to Day8/Day29

• Incidence of reaction of the injection sites

  Day1 to Day8/Day29

Secondary Outcomes (19)

• Pharmacokinetic (PK) profile of SHR-1816 - AUC0-t

  pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose

• Pharmacokinetic (PK) profile of SHR-1816 - AUC0-inf

  pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose

• Pharmacokinetic (PK) profile of SHR-1816 - Cmax

  pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose

• Pharmacokinetic (PK) profile of SHR-1816 - Tmax

  pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose

• Pharmacokinetic (PK) profile of SHR-1816 - Vz/F

  pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose

Study Arms (2)

Group A

EXPERIMENTAL

Drug: SHR-1816

Group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1816 DRUG

SHR-1816

Group A

Placebo DRUG

Placebo

Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• The following clinical laboratory tests or examination abnormalities exist during the screening period:
• \) 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.
• \) Positive infectious diseases screening tests: HBsAg, HCV-Ab, TP-Ig G, HIV-Ab 2. Having any of the following diseases or history:
• Subject with a history of hypertension or with abnormal vital signs and clinical significance.
• Subject with a history of life-threatening diseases within the previous 5 years prior to screening.
• Subject with severe systemic infectious diseases within 1 month prior to screening.
• Subject with medical history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, and previous history of pancreatitis.
• Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems.
• \. Use of any other medicine or other non-drug operations:
• Prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration.
• Subject who received bariatric surgery or procedures, or use of weight-reducing drugs within 3 months prior to administration, or body weight change of more than ±10% within 3 months prior to administration.
• Drugs that may affect glucose metabolism were used within 1 month before administration.
• Subject who undergone other gastrointestinal surgery that could lead to malabsorption, or long-term use of drugs that had a direct impact on gastrointestinal motility prior to screening.
• \. Any of the following conditions exists:
• History of allergy to the study drug or any component of it.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1816 injection compared with placebo

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 15, 2022
• Study Start: May 18, 2022
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)