A Trial of SHR-1905 in Healthy Subjects

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-11-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of SHR-1819 in Healthy Subjects

NCT04561128

Healthy Volunteers

COMPLETED PHASE1

Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects

NCT06995001

Healthy Volunteers

COMPLETED PHASE1

To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683

NCT01419600

Healthy

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants

NCT05143905

Safety Tolerability Pharmacokinetics +1 more

COMPLETED PHASE1

A Trial of SHR2285 in Healthy Subjects

NCT04829305

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SHR-1905 Dose Level 1

SHR-1905 Dose level 1

Group Type EXPERIMENTAL

SHR-1905

Intervention Type DRUG

SHR-1905 will be injected subcutaneously

Placebo

Intervention Type DRUG

Placebo will be injected subcutaneously

SHR-1905 Dose Level 2

SHR-1905 Dose level 2

Group Type EXPERIMENTAL

SHR-1905

Intervention Type DRUG

SHR-1905 will be injected subcutaneously

Placebo

Intervention Type DRUG

Placebo will be injected subcutaneously

SHR-1905 Dose Level 3

SHR-1905 Dose level 3

Group Type EXPERIMENTAL

SHR-1905

Intervention Type DRUG

SHR-1905 will be injected subcutaneously

Placebo

Intervention Type DRUG

Placebo will be injected subcutaneously

SHR-1905 Dose Level 4

SHR-1905 Dose level 4

Group Type EXPERIMENTAL

SHR-1905

Intervention Type DRUG

SHR-1905 will be injected subcutaneously

Placebo

Intervention Type DRUG

Placebo will be injected subcutaneously

SHR-1905 Dose Level 5

SHR-1905 Dose level 5

Group Type EXPERIMENTAL

SHR-1905

Intervention Type DRUG

SHR-1905 will be injected subcutaneously

Placebo

Intervention Type DRUG

Placebo will be injected subcutaneously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-1905

SHR-1905 will be injected subcutaneously

Intervention Type DRUG

Placebo

Placebo will be injected subcutaneously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening.
3. Subjects with infecious disease.
4. Hyper/Hypotension at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG
6. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
7. Positive urine drug screen .
8. Subject who cannot perform venous blood sampling.
9. Known history or suspected of being allergic to the study drugs and their excipients.
10. Use of any medicine within 4-weeks or within 5 half-lives
11. History of alcohol abuse within 3 months prior to the IP administration .
12. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
13. in the investigator's judgment, may increase the risk to the subject

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes