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CompletedPhase 1

A Trial 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

Atridia Pty Ltd.

Asset

SHR-1707

Listed sites

1

Recruiting sites

-

Enrollment

50

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age ≥18

Primary endpoint

Adverse events

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 IDNCT04745104
Org study IDSHR-1707-I-101-AUS

Timeline

Milestones

Study first posted2021-02-09actual
Study start2021-02-23actual
Primary completion2022-03-21actual
Study completion2022-03-21actual
Last update posted2022-07-12actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

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

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

Safety / tolerability / PK
9
Fluid / digital biomarkers
1
Other (unclassified)
1

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Pharmacodynamics

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

change from baseline, improvement

Safety / tolerability / PK

9 endpoints
Primary/protocol endpoint

Adverse events

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

event count, event

Secondary/protocol endpoint

Pharmacokinetics-AUC0-last

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

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics-AUC0-inf

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

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics-Tmax

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

time to event, event

Secondary/protocol endpoint

Pharmacokinetics-Cmax

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

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics-CL/F

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

descriptive

Secondary/protocol endpoint

Pharmacokinetics-Vz/F

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

descriptive

Secondary/protocol endpoint

Pharmacokinetics-t1/2

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

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics MRT

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

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Anti-Drug antibody

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

threshold achievement, improvement

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.