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CompletedPhase 1

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

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

NCT IDNCT04973189
Org study IDSHR-1707-101

Timeline

Milestones

Study start2021-05-08actual
Study first posted2021-07-22actual
Primary completion2022-01-13actual
Study completion2022-01-13actual
Last update posted2023-05-18actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

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

Other (unclassified)
6
Safety / tolerability / PK
4
Amyloid biomarkers
1

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

The 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 endpoints
Primary/protocol endpoint

Incidence 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

Secondary/protocol endpoint

Time to Cmax (Tmax) of SHR-1707

Time frame:Start of Treatment to end of study (approximately 12 weeks)

time to event, event

Secondary/protocol endpoint

Maximum observed concentration (Cmax) of SHR-1707

Time frame:Start of Treatment to end of study (approximately 12 weeks)

concentration, descriptive

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint/low confidence

Area 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

Secondary/protocol endpoint/low confidence

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

Secondary/protocol endpoint/low confidence

Clearance (CL) of SHR-1707

Time frame:Start of Treatment to end of study (approximately 12 weeks)

descriptive

Secondary/protocol endpoint/low confidence

Volume of distribution (Vss) of SHR-1707

Time frame:Start of Treatment to end of study (approximately 12 weeks)

descriptive

Secondary/protocol endpoint/low confidence

Mean residence time (MRT) of SHR-1707

Time frame:Start of Treatment to end of study (approximately 12 weeks)

descriptive

Secondary/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.