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

NCT04745104 | Completed Phase 1

• 1 other identifier: SHR-1707-I-101-AUS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 12 weeks)

Secondary Outcomes (10)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 12 weeks)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 12 weeks)

• Pharmacokinetics-Tmax

  Start of Treatment to end of study (approximately 12 weeks)

• Pharmacokinetics-Cmax

  Start of Treatment to end of study (approximately 12 weeks)

• Pharmacokinetics-CL/F

  Start of Treatment to end of study (approximately 12 weeks)

Study Arms (6)

SHR-1707 Dose level 1

EXPERIMENTAL

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

Drug: SHR-1707; Drug: Placebo

SHR-1707 Dose level 2

EXPERIMENTAL

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

Drug: SHR-1707; Drug: Placebo

SHR-1707 Dose level 3

EXPERIMENTAL

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

Drug: SHR-1707; Drug: Placebo

SHR-1707 Dose level 4

EXPERIMENTAL

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

Drug: SHR-1707; Drug: Placebo

SHR-1707 Dose level 5

EXPERIMENTAL

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

Drug: SHR-1707; Drug: Placebo

SHR-1707 Dose level 3 (Elderly subjects)

EXPERIMENTAL

SHR-1707 or placebo is administered intravenous to Elderly subjects

Drug: SHR-1707; Drug: Placebo

Interventions

SHR-1707 DRUG

SHR-1707 will be administered through IV infusion

SHR-1707 Dose level 1; SHR-1707 Dose level 2; SHR-1707 Dose level 3; SHR-1707 Dose level 3 (Elderly subjects); SHR-1707 Dose level 4; SHR-1707 Dose level 5

Placebo DRUG

Placebo will be administered through IV infusion

SHR-1707 Dose level 1; SHR-1707 Dose level 2; SHR-1707 Dose level 3; SHR-1707 Dose level 3 (Elderly subjects); SHR-1707 Dose level 4; SHR-1707 Dose level 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
• 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
• Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive) at screening and baseline
• 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
• WOCBP agree to take effective contraceptive methods

You may not qualify if:

• Severe injuries or surgeries within 6 months before screening
• ALT, or AST or total bilirubin level \<1.5x upper limit of normal range (ULN) at screening or baseline visits
• QTcF \> 450msec (Male), QTcF \> 470msec (Female) in 12-lead ECG test during screening and baseline
• Known history or suspected of being allergic to the study drug.
• 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
• Live (attenuated) vaccination within 1 month before screening
• Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
• History of alcohol abuse in the past 12 months of screening
• History of illicit or prescription drug abuse or addiction within 12 months of screening
• More than 5 cigarettes daily for 12 months before screening
• Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
• Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Atridia Pty Limited

Sydney, New South Wales, 2000, Australia

Location

Related Publications (1)

• 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.

  PMID: 39390616 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

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: December 1, 2020
• First Posted: February 9, 2021
• Study Start: February 23, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)