A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

NCT ID: NCT04745104

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-03-21

Brief Summary

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

Detailed Description

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 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

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SHR-1707 Dose level 1

SHR-1707 or placebo is administered intravenous to young healthy subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 2

SHR-1707 or placebo is administered intravenous to young healthy subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 3

SHR-1707 or placebo is administered intravenous to young healthy subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 4

SHR-1707 or placebo is administered intravenous to young healthy subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 5

SHR-1707 or placebo is administered intravenous to young healthy subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 3 (Elderly subjects)

SHR-1707 or placebo is administered intravenous to Elderly subjects

Group Type: EXPERIMENTAL

SHR-1707

Intervention Type: DRUG

SHR-1707 will be administered through IV infusion

Placebo

Intervention Type: DRUG

Placebo will be administered through IV infusion

Interventions

SHR-1707

SHR-1707 will be administered through IV infusion

Intervention Type: DRUG

Placebo

Placebo will be administered through IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,

2. Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2

3. Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive) at screening and baseline

4. Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects

5. WOCBP agree to take effective contraceptive methods

Exclusion Criteria

1. Severe injuries or surgeries within 6 months before screening

2. ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits

3. QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline

4. Known history or suspected of being allergic to the study drug.

5. Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives

6. Live (attenuated) vaccination within 1 month before screening

7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.

8. History of alcohol abuse in the past 12 months of screening

9. History of illicit or prescription drug abuse or addiction within 12 months of screening

10. More than 5 cigarettes daily for 12 months before screening

11. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening

12. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atridia Pty Limited

Sydney, New South Wales, Australia

Countries

Australia

References

Yang Y, Qiu H, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Zhang Q, Ye Z, Ma J, Xu Y, Feng S, Fei Y, Li N, Cui X, Dong F, Wang Q, Shen K, Shakib S, Williams J, Hu W. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. Alzheimers Res Ther. 2024 Oct 10;16(1):218. doi: 10.1186/s13195-024-01584-8.

Reference Type: DERIVED

PMID: 39390616 (View on PubMed)

Other Identifiers

SHR-1707-I-101-AUS

Identifier Type: -

Identifier Source: org_study_id