A Trial of SHR-1703 in Healthy Subjects

NCT04855591 | Terminated Phase 1

• 1 other identifier: SHR-1703-104-AUS
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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 pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 34 weeks)

Secondary Outcomes (9)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 34 weeks)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 34 weeks)

• Pharmacokinetics-Tmax

  Start of Treatment to end of study (approximately 34 weeks)

• Pharmacokinetics-Cmax

  Start of Treatment to end of study (approximately 34 weeks)

• Pharmacokinetics-CL/F

  Start of Treatment to end of study (approximately 34 weeks)

Study Arms (4)

SHR-1703 Dose Level 1

EXPERIMENTAL

Dose level 1 SHR-1703

Drug: SHR-1703; Drug: Placebo

SHR-1703 Dose Level 2

EXPERIMENTAL

Dose level 2 SHR-1703

Drug: SHR-1703; Drug: Placebo

SHR-1703 Dose Level 3

EXPERIMENTAL

Dose level 3 SHR-1703

Drug: SHR-1703; Drug: Placebo

SHR-1703 Dose Level 4 (optional)

EXPERIMENTAL

Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review

Drug: SHR-1703; Drug: Placebo

Interventions

SHR-1703 DRUG

SHR-1703 will be administered subcutaneously

SHR-1703 Dose Level 1; SHR-1703 Dose Level 2; SHR-1703 Dose Level 3; SHR-1703 Dose Level 4 (optional)

Placebo DRUG

Placebo of SHR-1703 will be administered subcutaneously

SHR-1703 Dose Level 1; SHR-1703 Dose Level 2; SHR-1703 Dose Level 3; SHR-1703 Dose Level 4 (optional)

Eligibility Criteria

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

You may qualify if:

• Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
• Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
• No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
• Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 30-days after last scheduled follow-up visit.

You may not qualify if:

• Known history or suspected of being allergic to the study drug.
• Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
• Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
• Use of any medicine within 4-weeks prior to the IP administration
• Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
• Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
• Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
• Patients with known or suspected parasitic infection within 6 months before screening
• Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
• More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
• History of alcohol abuse within 3 months prior to the IP administration

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Nucleus Network

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr Richard Friend

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: June 14, 2021
• Primary Completion: September 13, 2021
• Study Completion: November 18, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)