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

NCT04973189 | Completed Phase 1

• 1 other identifier: SHR-1707-101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

  Incidence and severity of adverse events

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

Secondary Outcomes (10)

• Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration

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

• Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration

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

• Time to Cmax (Tmax) of SHR-1707

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

• Maximum observed concentration (Cmax) of SHR-1707

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

• Terminal elimination half-life (t1/2) of SHR-1707

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

Study Arms (4)

A single dose of SHR-1707 by intravenous infusion in healthy young adults.

EXPERIMENTAL

Drug: SHR-1707

placebo in healthy young adults.

PLACEBO COMPARATOR

Drug: Placebo

A single dose of SHR-1707 by intravenous infusion in elderly subjects.

EXPERIMENTAL

Drug: SHR-1707

placebo in elderly subject

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1707 DRUG

A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.

A single dose of SHR-1707 by intravenous infusion in healthy young adults.

Placebo DRUG

A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.

placebo in healthy young adults.

Eligibility Criteria

• Age: 18 Years - 80 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, be able and willing to provide a written informed consent
• 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\~28 kg/m2 (inclusive)
• 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
• Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at 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 Aβ antibody
• 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
• The instigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1707 compared with placebo

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 22, 2021
• Study Start: May 8, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CN (1)