← Trials/Trial dossier/NCT04973189
A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects
Lead sponsor
Asset
SHR-1707
Listed sites
1
Recruiting sites
-
Enrollment
63
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 18-80
Primary endpoint
•Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
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 19~28 kg/m2 (inclusive)
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. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at screening
3. ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
4. QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
5. Known history or suspected of being allergic to Aβ antibody
6. 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
7. Live (attenuated) vaccination within 1 month before screening
8. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
9. History of alcohol abuse in the past 12 months of screening
10. History of illicit or prescription drug abuse or addiction within 12 months of screening
11. More than 5 cigarettes daily for 12 months before screening
12. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
13. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program
14. The instigators determined that other conditions were inappropriate for participation in this clinical trial
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Amyloid biomarkers
1 endpointThe change from baseline in plasma Aβ40 and Aβ42 concentrations
Time frame:Start of Treatment to end of study (approximately 12 weeks)
change from baseline, improvement
Safety / tolerability / PK
4 endpointsIncidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame:Start of Treatment to end of study (approximately 12 weeks)
event count, event
Time to Cmax (Tmax) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
time to event, event
Maximum observed concentration (Cmax) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
concentration, descriptive
Terminal elimination half-life (t1/2) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
concentration, descriptive
Other (unclassified)
6 endpointsArea under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration
Time frame:Start of Treatment to end of study (approximately 12 weeks)
concentration, descriptive
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration
Time frame:Start of Treatment to end of study (approximately 12 weeks)
concentration, descriptive
Clearance (CL) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
descriptive
Volume of distribution (Vss) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
descriptive
Mean residence time (MRT) of SHR-1707
Time frame:Start of Treatment to end of study (approximately 12 weeks)
descriptive
Number of subjects with Anti-SHR-1707 antibodies
Time frame:Start of Treatment to end of study (approximately 12 weeks)
event count, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID39390616via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.